Clinical trials: Kidney Insufficiency
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal…
- Trial name
- AiME - 04 (NCT01628120)
- Testing
- Epoetin Hospira
- Where
- 115 sites in United States
- Volunteers
- 170 people
- Sponsor
- Pfizer
Renal Impairment
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment
The primary objectives of this study are to evaluate the pharmacokinetics (PK) following administration of gabapentin in Japanese epileptic patients with renal impairment to confirm if there are any clinically relevant…
- Trial name
- NCT00785772
- Testing
- Gabapentin
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Renal Failure
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly…
- Trial name
- LCPTacro3002 (NCT01187953)
- Testing
- Prograf (tacrolimus), LCP-Tacro
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 543 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Failure, Chronic
Clinical Study of Asahi ViE Dialyzer in Canada
The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .
- Trial name
- AVID (NCT02292212)
- Testing
- ViE-21
- Volunteers
- 17 people
- Sponsor
- Asahi Kasei Medical Co., Ltd.
End Stage Renal Disease
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based…
- Trial name
- NCT01130831
- Testing
- Lanthanum carbonate
- Where
- 31 sites in Germany
- Volunteers
- 66 people
- Sponsor
- Shire
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Heart Failure; With Decompensation, Cardiorenal Syndrome
The Aortix CRS Pilot Study
The Aortix CRS Pilot Study: An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome
- Conditions
- Heart Failure; With Decompensation, Cardiorenal Syndrome, Cardio-Renal Syndrome, Heart Failure
- Trial name
- NCT04145635
- Testing
- Aortix System
- Where
- 19 sites in United States, Australia
- Volunteers
- 21 people
- Sponsor
- Procyrion
Gout, Chronic Kidney Disease (CKD)
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
- Trial name
- NCT03226899
- Testing
- Lesinurad, XOI, colchicine
- Where
- 116 sites in United States, Czechia and 2 more
- Volunteers
- 242 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Type 2 Diabetes Mellitus
Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment
This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM…
- Trial name
- NCT02836873
- Testing
- Bexagliflozin
- Where
- 56 sites in United States, France and 2 more
- Volunteers
- 312 people
- Sponsor
- Theracos
Type 2 Diabetes Mellitus, Chronic Kidney Disease
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
- Trial name
- NCT03270956
- Testing
- Renal Autologous Cell Therapy (REACT)
- Where
- 4 sites in United States
- Volunteers
- 10 people
- Sponsor
- Prokidney
Kidney Failure, Chronic
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease…
- Trial name
- LEAP (NCT00853242)
- Testing
- Genz-644470, Sevelamer carbonate
- Where
- 53 sites in United States, Puerto Rico
- Volunteers
- 349 people
- Sponsor
- Genzyme, a Sanofi Company
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Renal Insufficiency
Renal Safety Evaluation After Dotarem®-Enhanced MRI
Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial.
- Trial name
- RESCUE (NCT00650845)
- Testing
- Dotarem®-enhanced MRI, non-enhanced MRI
- Where
- 15 sites in Belgium, France and 2 more
- Volunteers
- 135 people
- Sponsor
- Guerbet
Anemia, Renal Diseases
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney…
- Trial name
- NCT00440466
- Testing
- epoetin alfa
- Where
- 66 sites in United States
- Volunteers
- 430 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IgA Nephropathy
Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation
Efficacy and safety of LNP023 in IgAN patients
- Trial name
- NCT03373461
- Testing
- LNP023
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 112 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Kidney Disease (CKD)
A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis
A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
- Trial name
- NCT02504294
- Testing
- Epoetin Hospira Arm, Standard of Care Arm, IV Iron
- Where
- 45 sites in United States, Puerto Rico
- Volunteers
- 432 people
- Sponsor
- Pfizer
End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD)
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal…
- Conditions
- End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
- Trial name
- NCT05769595
- Testing
- MK-2060
- Where
- 12 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease (CKD), Hyperkalemia (HK)
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia (OPAL)
The purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium).
- Trial name
- OPAL (NCT01810939)
- Testing
- Patiromer
- Where
- 58 sites in United States, Croatia and 8 more
- Volunteers
- 243 people
- Sponsor
- Relypsa, Inc.