Clinical trials: Urinary System Disorder
Congenital Cystic Kidney Disease
Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- STAGED-PKD-EXT (NCT04705051)
- Testing
- Venglustat GZ402671
- Where
- 11 sites in United States, Australia and 6 more
- Volunteers
- 24 people
- Sponsor
- Sanofi
Advanced/Metastatic Clear Cell Renal Cell Carcinoma
Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
This is a Phase 1 dose escalation study using a 3+3 study design, followed by a phase 1b expansion study. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced…
- Trial name
- TRAVERSE (NCT04696731)
- Testing
- ALLO-316, ALLO-647, Fludarabine
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Allogene Therapeutics
Hypertension, Vascular Diseases
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SWYFT (NCT07115953)
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 21 sites in Australia, Belgium and 7 more
- Volunteers
- 130 people
- Sponsor
- Medtronic Vascular
Urinary Tract Infections
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment.
- Trial name
- NCT04371159
- Testing
- Velieve U.S.
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Healthy.io Ltd.
Carcinoma, Renal Cell
Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.
The purpose of this study is to: 1. To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and possible early effect of hypophosphatemia on bone mineral density 2.
- Trial name
- NCT00622479
- Testing
- Sorafenib (Nexavar, BAY43-9006)
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- Bayer
Diabetic Nephropathy
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout.
- Trial name
- UPWARD (NCT02327754)
- Testing
- Topiroxostat BID, (Oral daily dosing for 28 weeks)
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
Renal Insufficiency, Chronic
Study to Assess the Safety and Impact on Humoral Sensitization of SANGUINATE in Patients With End Stage Renal Disease
A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
- Trial name
- NCT02437422
- Testing
- SANGUINATE
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Prolong Pharmaceuticals
Renal Cell Carcinoma
A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment…
- Trial name
- LITESPARK-033 (NCT07227402)
- Testing
- Belzutifan, Zanzalintinib, Cabozantinib
- Where
- 127 sites in United States, Argentina and 21 more
- Volunteers
- 904 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Kidney Injury, Peritonitis
Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury
Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.
- Conditions
- Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection
- Trial name
- NCT03403751
- Testing
- Reltecimod 0.5 mg/kg
- Where
- 56 sites in United States, France
- Volunteers
- 58 people
- Sponsor
- Atox Bio Ltd
Bladder Cancer
Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors
This is a phase II, single center open label to determine safety, dose tolerance, PK and PD of the recommended Phase 2 dose (RP2D) of CPX-POM administered in patients with any newly diagnosed or recurrent bladder tumors.
- Trial name
- NCT04525131
- Testing
- CPX-POM
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- CicloMed LLC
Colorectal Cancer, Non-small Cell Lung Cancer
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
- Conditions
- Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Renal Cell Carcinoma
- Trial name
- NCT03576131
- Testing
- GEN1029 (HexaBody®-DR5/DR5)
- Where
- 6 sites in United States, Spain and 1 more
- Volunteers
- 48 people
- Sponsor
- Genmab
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants.
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04265781
- Testing
- BAY1817080
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Overactive Bladder, Detrusor Overactivity
A Study To Assess If 10 mg Vardenafil (BAY38-9456) Taken Twice Daily For 6 Weeks Has An Effect On Bladder Function
The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency.
- Trial name
- NCT00478881
- Testing
- Vardenafil HCl (Levitra, BAY38-9456)
- Where
- 55 sites in Belgium, Canada and 11 more
- Volunteers
- 397 people
- Sponsor
- Bayer
Polycystic Kidney
Lixivaptan in a Single Subject With Intractable Pain Due to Polycystic Kidney Disease
Abdominal pain, sometimes severe, is a known symptom of polycystic kidney disease (PKD) related to the cystic expansion. This study will investigate whether the vasopressin V2 receptor antagonist lixivaptan can alleviate…
- Trial name
- NCT03717181
- Testing
- Lixivaptan
- Where
- United States
- Sponsor
- Palladio Biosciences
End Stage Renal Disease on Hemodialysis (Diagnosis)
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
- Trial name
- NCT03934736
- Testing
- HEPLISAV-B®
- Where
- 20 sites in United States
- Volunteers
- 119 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Kidney Disease
Dialysis Clinical Outcomes Revisited (DCOR) Trial
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients.
- Trial name
- NCT00324571
- Testing
- Sevelamer hydrochloride, Calcium-based phosphate binder
- Where
- 73 sites in United States, Puerto Rico
- Volunteers
- 2,000 people
- Sponsor
- Genzyme, a Sanofi Company
Kidney Disease
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy.
- Trial name
- BREAKOUT (NCT05709444)
- Testing
- Bremelanotide, RAAS inhibition therapy
- Where
- 9 sites in United States
- Volunteers
- 16 people
- Sponsor
- Palatin Technologies, Inc
Cancer, Cancer Central Nervous System
Prospective Data Registry and Quality of Life Assessment of Patients Undergoing Radiotherapy With the RefleXion Medical Radiotherapy System
The purpose of this prospective cohort study is to assess clinical and quality of life measures as well as to define the severity of adverse effects for the use of the RefleXion system to deliver intensity-modulated radiotherapy…
- Conditions
- Cancer, Cancer Central Nervous System, Cancer Thoracic, Cancer, Gastrointestinal
- Trial name
- PREMIER (NCT05406167)
- Testing
- Registry - Observational
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- RefleXion Medical
Cushing Syndrome
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
- Trial name
- NCT03708900
- Testing
- LCI699
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 12 people
- Sponsor
- RECORDATI GROUP
Primary Hyperoxaluria
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),
- Trial name
- NCT04125472
- Testing
- Lumasiran
- Sponsor
- Alnylam Pharmaceuticals
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