Search Results Within Category "Kidney, Prostate & Urinary"
A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) and Pembrolizumab in Combination with Other Investigational Agents in Subjects with High-risk Non-muscle-Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy
This trial will evaluate other treatment options for high-risk NMIBC patients who were unresponsive to Bacillus Calmette Guerin (BCG therapy). We are studying two different drugs in combination with pembrolizumab. Participants will receive up to 35 doses of the trial drug and have tumor assessments for about 2 years. This will be followed by treatment tumor assessment for another 3 years for a total trial duration of 5 years.
• confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ) transitional cell carcinoma of the bladder
• tumor has been completely removed with bladder surgery
• BCG-unresponsive high risk non-muscle-invasive bladder cancer after treatment with adequate BCG therapy
• ineligible for radical cystectomy or refusal of radical cystectomy
• able to care for self, up and about for at least half of the day
• participants of child bearing age must be willing to use effective birth control
• received intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy / Transurethral Resection of Bladder Tumor (TURBT)
• active autoimmune disease that has required systemic treatment in the past 2 years
• active infection requiring systemic therapy
• pregnant or breast feeding
• contact study staff for additional study eligibility criteria
Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy (REBOOT)
People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. This study will measure belimumab in the blood to decide if people with high urine protein should receive a higher dose of belimumab. Another purpose of this study is to help learn about whether the combination of belimumab and rituximab treatment is effective in making and keeping Primary MN inactive.
• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries
This research is being to see if a new 3D simulation model is helpful in teaching patients about care of their stomas after surgery. We expect that people will be in this research study for 3-6 months depending on the timing of surgery and postoperative visits. The number of preoperative and postoperative visits, physician exams, scans, X-rays, and laboratory tests for preparation for surgery or after the surgery does not change because of this study.
• at least 18 years old
• having bowel diversion urologic surgery
• prior or current ostomy
• women who are pregnant
• cognitively unable to care for own stoma
Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial
This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.
• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
Minnesota KPMP CKD and Resilient Diabetes Recruiting Site (KPMP)
The Kidney Precision Medicine Project (KPMP) is a research study. Our goal is learn more about kidney injury and kidney disease. By studying your kidneys, we may learn more about why chronic kidney disease happens and how to treat it more effectively or even how to prevent it. Or participants have had diabetes for many years and have not clinical signs of chronic kidney disease. By studying your kidneys, we may learn more about the factors that help protect you from kidney disease. KPMP will last for at least 10 years.
• at least 18 years old
• diagnosis acute or chronic kidney (renal) disease with diabetes mellitus (type 1 or 2) OR associated with hypertension
• persistent kidney damage based on specific lab values at least 3 months apart (study staff will review)
• Body Mass Index (BMI) greater than 40 kg/m2
• any allergic reaction to iodinated contrast
• receiving chemotherapy or radiation to treat cancer
• transplant recipient (includes solid transplant and bone marrow)
• unwilling to receive blood transfusion (if needed)
• women who are pregnant
A multicenter, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult atypical hemolytic uremic syndrome (aHUS) patients who are naive to complement inhibitor therapy (APPELHUS)
To evaluate the efficacy and safety of iptacopan at a dose of 200 mg twice a day for 52 weeks in patients with atypical hemolytic uremic syndrome (aHUS).
• at least 18 years old
• evidence of active Thrombotic Microangiopathy (TMA)
• previous or ongoing treatment with complement inhibitors, including anti-C5 antibody
• ADAMTS13 deficiency
• positive test for Shiga toxin * direct Coombs test
• had a bone marrow transplant or hematopoietic stem cell transplant, or a heart, lung, small bowel, pancreas or live transplant
A Phase II, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis
The main purpose of this study is to check how safe the study drug is and how well your body handles taking it. We will also check if the study drug works to improve your kidney function, if has an impact on your daily life and the amount of the study drug in your blood over a period of time (called pharmacokinetics)
• at least 12 years of age
• for people with Alport Syndrome: confirmed diagnosis by genetic testing and /or kidney biopsy
• for primary Focal Segmental Glomerulosclerosis (FSGS), (without any identifiable cause, and where the FSGS is confirmed by renal biopsy) or FSGS where there is documentation of a genetic mutation in a podocyte protein
• female patients, as well as, female partners of male patients who are of child-bearing potential must be willing to not become pregnant for the complete duration of the study (90 days after the last dose of study medication)
• males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug
• contact study staff for additional criteria
• uncontrolled diabetes mellitus as evidenced by an HbA1c greater or equal to 11%
• uncontrolled high blood pressure
• moderate or severe liver impairment
• BMI greater than 40
• women who are pregnant or breast feeding
• additional exclusion criteria apply (study staff will review)
Prospective, Multicenter, Single-Arm Study of VanquishTM Water Vapor Ablation for PrOstate CanceR (VAPOR 2)
The purpose of this study is to determine the safety and efficacy of the Vanquish System treatment in men who have intermediate risk prostate cancer. In this study, the Vanquish System will be used to destroy cancerous tissue in the prostate. After treatment, participants will undergo tests that will assess presence of prostate cancer.
• 50 years or older
• PSA no more than 15 ng/ml
• cancer stage less than or equal to T2c
• had a multiparametric MRI within the last 12 months and MRI software guided fusion biopsy of the prostate within the last 6 months
• prior surgery, intervention, or minimally invasive therapy, for the prostate cancer or bladder neck
• taking medications that have hormonal effects on the prostate or PSA or or testosterone supplement
• significant medical or mental health diagnosis (study staff will review)
A Phase 3 open-label, controlled, randomised, multi-centre trial comparing imlifidase and standard-of-care with standard-of-care alone in the treatment of severe anti-GBM antibody disease (Goodpasture disease) (GOOD-IDES-02)
The purpose of the trial is to evaluate the effect and safety of imlifidase when given to participants with antiGBM disease (also called Goodpasture disease). We will study if the addition of imlifidase to the standard of care treatment results in a better effect without causing unacceptable side effects compared to standard of care alone.
• Anti-GBM antibodies constituting an indication for Plasma exchange (PLEX)
• presence of blood or sediment in urine
• diagnosis of anti-GBM disease made more than 14 days ago
• women who are pregnant or breast feeding
• additional exclusion criteria (study staff will review)
The Women Kidney Program
The purpose of this study is to capture clinical information on how kidney disease affects the health of women, focusing on menstrual and reproductive health, the transition to menopause (the time when your menstrual periods stop permanently), and menopause itself. We also wish to learn more about how women’s health affects their kidney disease, bone and heart health.
• female as biological sex
• diagnosis of a kidney disease or after kidney transplant
• at least 18 years old
• unable to speak English
NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)
Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.
• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
The purpose of this study is to test whether the investigational drug, tegoprubart, in combination with the same standard immunosuppressive medicines (anti-thymocyte globulin, corticosteroids, and mycophenolate) is safe, tolerable and effective compared to tacrolimus. The study will specifically look at the function of the implanted kidney in the tegoprubart group compared to the tacrolimus group and will also assess how well tegoprubart prevents diabetes and prevents rejection.
• 18 to 100 years old
• recipient of first kidney transplant from a living or deceased donor
• agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
• previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
• medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
• additional criteria apply (study staff will review)
A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis (VOCAL)
The aim of this study is to investigate whether voclosporin, added to standard treatment, is able to reduce activity of lupus nephritis over a study treatment period of 24 weeks, and to determine its safety as well as the best dose for treatment of lupus nephritis in children or adolescents.
• 12 to 17 years old
• diagnosis of systemic lupus erythematosus (SLE)
• active lupus nephritis confirmed by a kidney biopsy
• currently need dialysis
• clinically significant active medical or mental health conditions (study staff will review)
• certain medications, including: immunosuppression biologic agents, cyclophosphamide, calcineurin inhibitors (CNIs), start or change dose of ACE inhibitors/ARBs within 4 weeks prior to starting study, IV corticosteroids and IV immunoglobulin within 2 weeks of starting study
A Phase 2, Open-Label, Single-Arm, Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sparsentan Treatment in Pediatric Subjects with Selected Proteinuric Glomerular Diseases (EPPIK) (EPPIK)
Currently, there are no approved treatment options for pediatric subjects with proteinuric kidney conditions. The study will look at the safety, efficacy, and pharmacokinetic (PK) trial in children ≥1 to <18 years treated for up to 108 weeks with the drug sparsentan.
• Child 1 to 18 years old
• Diagnosed by biopsy with specific types of glomerular disease & protein in the urine
• Blood pressure is within normal range for age
• Maintained on a stable dose of immunosuppressive medications
• Weight less than 7.3 kg 16 pounds) at screening.
• Disease due to to viral infections, drug toxicities, or cancer.
• Kidney function is below the minimum required
A prospective, randomized, controlled, blinded study to assess the Safety and Efficacy of the Butterfly Medical Prostatic Retraction Device in Benign Prostatic Hyperplasia (BPH) Patients.
The purpose of this study is to assess the safety and effectiveness of the Butterfly study device in reducing the symptoms that are associated with the BPH condition. Another purpose is to assess sexual function and quality of life following the use of the Butterfly study device. The Butterfly study device includes a metal (nitinol) implant that looks like a butterfly. The implant is inserted through the urethra - the tube that carries pee out of the body, and resides at the area of the prostate.
• men who are 50 to 80 years old
• symptomatic BPH
• additional criteria apply, study staff will review
• known sensitivity to Nickel
• current urinary retention
• urinary stress incontinence
• currently active bladder tumor or intravesical instillation
• additional exclusion criteria related to prostate or urinary tract function (study staff will review)
CANADIAN-AUSTRALASIAN RANDOMISED TRIAL OF SCREENING KIDNEY TRANSPLANT CANDIDATES FOR CORONARY ARTERY DISEASE (CARSK)
The current study is designed to determine which strategy (regular screening or screening only in the presence of symptoms) is more effective in preventing heart attacks in kidney transplant candidates. Another goal of the study is to determine whether biomarker tests are able to predict the need for regular CAD screening tests.
• Dialysis-dependent kidney failure and currently being assessed for OR active on the kidney transplant waiting list
• expected to require further screening for coronary artery disease (CAD) prior to transplant
• anticipated to undergo transplant more than 12 months from date of enrollment
• patients with signs or symptoms suggestive of uncontrolled cardiac disease such as unstable coronary syndromes, decompensated heart failure, uncontrolled arrhythmia, and severe valvular heart disease
• patients with other solid organ transplants
• multi-organ transplant candidates
• planned living donor transplant
Immune Modulation Associations With Urinary tract Infection In People With Neurogenic Bladder.
The goal of this study is to understand how urine and bladder tissue changes from infection, or a bladder that does not function normally, in people who use a catheter to empty their bladder. This may help future people because it can help determine who needs antibiotics to treat an infection in the bladder, and will help avoid the cost and side effects of using antibiotics in people who do not have a true infection. This study will take less than 1 hour – the time required to provide a urine sample in clinic. Or, if a participant is undergoing bladder Botox injection, the time necessary to participate in the study will add approximately 5 minutes to the total surgery time.
• at least 18 years old
• use clean intermittent catheterization (CIC) to empty the bladder
• without diagnosis of neurogenic bladder (NGB)
• OR NGB managed with bladder botulinum toxin injections with/without recurrent urinary tract infection (UTI) (may have an active UTI)
• presence of an indwelling catheter (i.e., Foley)
• history of bladder augmentation
• history of urinary diversion
• women who are pregnant
• non-English speaker
A Phase 2, Open-Label, Basket Study of Atrasentan in Patients with Proteinuric Glomerular Diseases (AFFINITY)
The purpose of the research is to find out if atrasentan delays worsening of kidney function in IgAN, FSGS, and Alport Syndrome.
• Age 18 years and older for patients in the IgAN, FSGS, and Alport Syndrome cohorts
• age 18-70 years for patients in the DKD cohort
• receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks
• there are different requirements for each diagnosis category & study staff will review these
• current diagnosis of another cause of chronic kidney disease or another primary glomerulopathy
• history of kidney transplantation or other organ transplantation
• except for FSGS patients, use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months
• blood pressure above 150 mmHg systolic or 95 mmHg diastolic
• history of heart failure or a previous hospital admission for fluid overload.
• history of liver disease
• hemoglobin below 9 g/dL or blood transfusion for anemia within the past 3 months.
• cancer in the past 5 years (except nonmelanoma skin cancer and curatively treated cervical carcinoma in situ)
• women who are pregnant, breastfeeding, or intend become pregnant during the study
• recently received an investigational agent -clinically significant unstable or uncontrolled medical condition (study staff will review)
Composur, A Patient-centric, Phase IV, Open-label, Prospective, Real World US Study to Evaluate Vibegron on Patient Treatment Satisfaction, Quality of Life, and Healthcare Resource Utilization in Patients with Overactive Bladder
This study will evaluate treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with vibegron for the treatment of OAB in the context of real-world clinical practice.
• diagnosis of overactive bladder (OAB) with or without urgency urinary incontinence
• symptoms of OAB for at least 3 months
• specific previous treatments for OAB (study staff will review)
• neurologic conditions associated with OAB symptoms, e.g., multiple sclerosis
• women who are pregnant or breast feeding or planning to become pregnant
CureGN: Cure Glomerulonephropathy Network Version 2.0
The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.
• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: diabetes mellitus (except gestational or diet controlled), diabetic glomerulosclerosis, systemic lupus erythematosus, HIV infection, active malignancy (except for non-melanoma skin cancer), active Hepatitis B or C infection, defined as positive viral load
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
This study is being done to improve outcomes after kidney donation and kidney transplantation. We will test kidney donors and kidney transplant recipients for apolipoprotein L1 gene (called APOL1) variants (or forms of the gene) and to see how these may affect them. Genes control the traits inherited from your family such as your eye color or blood type. Only a blood sample (and possibly urine) will be collected. Information routinely collected as part of surgery will also be used in the study. There will not be any changes to usual medical care.
• living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African)
• people who have received a kidney transplant from an eligible living or deceased donor with recent African ancestry
• people who have received multi-organ transplants including a kidney plus an additional organ (i.e. liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants
Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry