Clinical trials: Diseases of the Urinary System
Chronic Kidney Disease, Type 2 Diabetes
Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)
A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001).
- Trial name
- RMCL-CL001 (NCT02525263)
- Testing
- Neo-Kidney Augment
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Prokidney
Renal Cell Carcinoma (RCC), Alveolar Soft Part Sarcoma (ASPS)
Phase 2 Study in Patients With MiT Tumors
This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors.
- Conditions
- Renal Cell Carcinoma (RCC), Alveolar Soft Part Sarcoma (ASPS), Clear Cell Sarcoma (CCS)
- Trial name
- NCT00557609
- Testing
- ARQ 197
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 47 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Hyperphosphatemia, End-stage Renal Disease
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).
- Conditions
- Hyperphosphatemia, End-stage Renal Disease, Renal Failure Chronic Requiring Hemodialysis
- Trial name
- NCT00967993
- Testing
- ferric citrate
- Where
- 3 sites in Israel
- Volunteers
- 22 people
- Sponsor
- Keryx Biopharmaceuticals
Secondary Hyperparathyroidism, End-Stage Renal Disease
Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT).
- Trial name
- NCT01134315
- Testing
- Paricalcitol, Calcitriol
- Where
- 18 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Kidney Transplant, Kidney Failure
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Trial name
- NEWHOPE (NCT07792317)
- Testing
- Omnisol organ preservation solution
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Vivalyx GmbH
ccRCC, RCC
A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-001)
PART 1: The primary objective of this study is to identify the maximum tolerated dose (MTD) of MK-3795, formerly called PT2385 and/or the recommended Phase 2 dose (RP2D) of MK-3795 in patients with advanced clear cell renal cell…
- Conditions
- ccRCC, RCC, Kidney Cancer, Clear Cell Renal Cell Carcinoma
- Trial name
- NCT02293980
- Testing
- MK-3795, Nivolumab, Cabozantinib
- Where
- 25 sites in United States
- Volunteers
- 110 people
- Sponsor
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
- Trial name
- EVEREST-I (NCT03423979)
- Testing
- Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
- Where
- 5 sites in Dominican Republic, Panama
- Volunteers
- 80 people
- Sponsor
- Urotronic Inc.
Renal Impairment
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
This is an open-label, single dose study designed to assess the pharmacokinetics and safety of ABT-493 and ABT-530 in subjects with either normal renal function or impaired renal function.
- Trial name
- NCT02442258
- Testing
- ABT-493, ABT-530
- Where
- 3 sites in United States, New Zealand
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- AbbVie
Vulvar and Vaginal Atrophy
Study to Evaluate the Equivalence of Estradiol Vaginal Cream to Reference Standard in the Treatment of Vaginal Atrophy
The objectives of this study are to evaluate the therapeutic equivalence of the Test formulation, Estradiol Vaginal Cream 0.01% (Prasco, LLC) to the marketed product, Estrace® Cream (estradiol vaginal cream, 0.01%) in patients…
- Trial name
- NCT03332303
- Testing
- Estrace® Cream, Estradiol Vaginal Cream, Vehicle Cream
- Where
- 27 sites in United States
- Volunteers
- 540 people
- Sponsor
- Prasco LLC
Overactive Bladder
Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")
The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.
- Trial name
- INTIMO2 (NCT02674269)
- Testing
- 300 IU of BotuGelTM (60ml), 400 IU of BotuGelTM (60ml), TC-3 Gel
- Where
- 2 sites in Israel
- Sponsor
- UroGen Pharma Ltd.
Atypical Hemolytic Uremic Syndrome, aHUS
Observational Study of Elizaria® in aHUS Patients
It is a multicenter observational non-comparative study of the efficacy and safety of long-term pathogenetic Elizaria® therapy in patients with atypical Hemolytic Uremic Syndrome
- Trial name
- NCT04749810
- Testing
- Elizaria®
- Where
- 8 sites in Russia
- Volunteers
- 50 people
- Sponsor
- AO GENERIUM
Urinary Bladder, Overactive
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is…
- Trial name
- NCT01566760
- Testing
- fesoterodine fumarate
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
End Stage Renal Disease
Evaluation of STARgraft-2 for Hemodialysis Access
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-2 hemodialysis access graft.
- Trial name
- NCT04783779
- Testing
- Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- Healionics Corporation
End Stage Renal Disease
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to…
- Trial name
- NCT06329310
- Testing
- aXess-E conduit
- Where
- 2 sites in Portugal, Serbia
- Volunteers
- 20 people
- Sponsor
- Xeltis
Urination Disorders
An Effectiveness and Safety Study Comparing Oxybutynin Chloride Plus FLOMAX (Tamsulosin HCl) and Placebo Plus FLOMAX (Tamsulosin HCl) for the Treatment of Lower Urinary Tract Symptoms.
The purpose of this study is to evaluate the safety and effectiveness of oxybutynin extended release tablets 10 mg plus tamsulosin HCl 0.4 mg in the treatment of lower urinary tract symptoms as measured by change of the total…
- Trial name
- NCT00338624
- Testing
- oxybutynin chloride extended release
- Volunteers
- 420 people
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Bladder Neoplasms, Ureteral Neoplasms
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium
Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma…
- Conditions
- Bladder Neoplasms, Ureteral Neoplasms, Urethral Neoplasms, Carcinoma, Transitional Cell
- Trial name
- NCT00077688
- Testing
- TOCOSOL Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- Achieve Life Sciences
Urinary Bladder, Overactive
FemPulse Therapy for Overactive Bladder in Women
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
- Trial name
- EVANESCE-OAB (NCT03784170)
- Testing
- FemPulse System
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- FemPulse Corporation
Advanced Cancer, Advanced Solid Tumor
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis
- Trial name
- NCT06362369
- Testing
- Alintegimod, Ipilimumab, Nivolumab
- Where
- 5 sites in United States
- Volunteers
- 126 people
- Sponsor
- 7 Hills Pharma, LLC
Urinary Bladder, Overactive
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Patients with overactive bladder are often treated with tolterodine, a medication that helps relax the bladder, helping symptoms of urinary incontinence and urinary frequency.
- Trial name
- NCT01302054
- Testing
- Fesoterodine 8 mg
- Where
- 176 sites in United States, Bulgaria and 13 more
- Volunteers
- 990 people
- Sponsor
- Pfizer
IgA Nephropathy, Lupus Nephritis (LN)
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy…
- Conditions
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- Trial name
- NCT06419205
- Testing
- ADX-097
- Where
- 4 sites in United States, Brazil
- Volunteers
- 30 people
- Sponsor
- Akebia Therapeutics
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