Clinical trials: Renal Insufficiency / Therapy
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01222884
- Testing
- Monofer, Iron sucrose
- Where
- India
- Volunteers
- 351 people
- Sponsor
- Pharmacosmos A/S
Chronic Kidney Disease
Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK).
- Trial name
- NCT04532918
- Testing
- Verinurad, Allopurinol, Cyclosporine
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 2, Kidney Function Tests
The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
The purpose of this study is to evaluate how dapagliflozin mechanism of action is impacted by Type 2 Diabetes Mellitus status and kidney function
- Trial name
- DAPASALT (NCT03152084)
- Testing
- Dapagliflozin
- Where
- 4 sites in Netherlands, Sweden
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
End-Stage Renal Disease, Hepatitis C
Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time.
- Trial name
- EXPANDER-1 (NCT02781649)
- Testing
- Zepatier, Ribavirin, Sofosbuvir
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
End Stage Renal Disease
A Safety Study of Pentoxifylline for the Treatment of Anemia
Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease.
- Trial name
- NCT01102218
- Testing
- Erythropoietin, Pentoxifylline
- Where
- 10 sites in United States
- Volunteers
- 48 people
- Sponsor
- Fresenius Medical Care North America
Type 2 Diabetes, Chronic Kidney Diseases
Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD
In Aim 1 of this study, the investigators will utilize community organizations to screen Hispanics/Latino(a)s for kidney disease, diabetes, and other risk factors, and refer them for care with a PCP.
- Trial name
- NCT05734989
- Testing
- BP, HbA1c, PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- Duke University
Chronic Kidney Disease, Secondary Hyperparathyroidism
Quality of Life in Greek Hemodialysis Patients Receiving Zemplar Intravenous
The purpose of this study is to assess health-related Quality of Life (QoL) changes in participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (sHPT) undergoing hemodialysis and receiving paricalcitol…
- Trial name
- QUALITIZE (NCT01368042)
- Where
- 11 sites in Greece
- Volunteers
- 265 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Liver Failure
A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation
This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult patients receiving a single organ liver transplant from a deceased donor; the purpose being to determine the efficacy of Thymoglobulin®…
- Trial name
- NCT02544113
- Testing
- Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- The Cleveland Clinic
Acute Kidney Failure
Protocol to Assess the Severity of Acute Kidney Injury
The principal objective is to safely determine if we can identify the severity of Acute Kidney Injury (AKI) early in the course of the disease. Once enrolled, we will draw blood and urine for relevant biomarkers.
- Trial name
- AKI (NCT00673244)
- Testing
- Furosemide
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- George Washington University
Chronic Kidney Disease
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney…
- Trial name
- NCT00858637
- Testing
- MCI-196, Simvastatin
- Where
- 39 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 260 people
- Sponsor
- Tanabe Pharma Corporation
Kidney Failure, Chronic Therapy; Hemodialysis
A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.
The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate
- Trial name
- NCT01920854
- Testing
- soluble ferric pyrophosphate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Rockwell Medical Technologies, Inc.
Acute Heart Failure
Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess safety, tolerability and pharmacokinetics and to explore efficacy of IV infusion of 10 µg/kg/day and 30 µg/kg/day serelaxin for 48 hours compared…
- Trial name
- NCT02002702
- Testing
- Serelaxin
- Where
- 15 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
CKD Anemia
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
- Trial name
- NCT01750190
- Testing
- Roxadustat
- Where
- 145 sites in United States, Argentina and 14 more
- Volunteers
- 922 people
- Sponsor
- Kyntra Bio
End Stage Renal Disease (ESRD), Diabetes
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients…
- Conditions
- End Stage Renal Disease (ESRD), Diabetes, CAPD
- Trial name
- EDEN (NCT01219959)
- Testing
- Dianeal, Dianeal, Extraneal, Nutrineal
- Where
- 16 sites in Colombia
- Volunteers
- 71 people
- Sponsor
- Vantive Health LLC
Arthroplasty, Replacement, Prevention of Venous Thromboembolism
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip…
- Conditions
- Arthroplasty, Replacement, Prevention of Venous Thromboembolism, Moderate Renal Impairment (CrCl 30-50 mL/Min)
- Trial name
- NCT01184989
- Testing
- Dabigatran etexilate
- Where
- 10 sites in Austria, Canada and 4 more
- Volunteers
- 142 people
- Sponsor
- Boehringer Ingelheim
Hepatorenal Syndrome
Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of…
- Trial name
- NCT02123576
- Testing
- Pentoxyfylline, AMO Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Patrick Northup, MD
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio
Anemia, Chronic Kidney Disease (CKD)
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously.
- Trial name
- ACCESS (NCT01693029)
- Testing
- HX575 epoetin alfa, US-licensed epoetin alfa
- Where
- 52 sites in United States
- Volunteers
- 435 people
- Sponsor
- Sandoz
Critically Ill Renal Failure Requiring CVVHD and Oseltamivir, Critically Ill Requiring ECMO and Oseltamivir
Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)
Critically ill patients with flu may receive a drug called oseltamivir. They may also receive medical therapies to support their lung function (extracorporeal membrane oxygenation; ECMO) and kidney function (continuous venovenous…
- Trial name
- NCT01048879
- Testing
- pharmacokinetic blood sampling, pharmacokinetic blood and dialysate sampling
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Michigan
Chronic Kidney Disease, Depression
Chronic Kidney Disease Antidepressant Sertraline Trial
This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started…
- Trial name
- CAST (NCT00946998)
- Testing
- Sertraline
- Where
- 2 sites in United States
- Volunteers
- 201 people
- Sponsor
- VA Office of Research and Development