Clinical trials: Renal Failure
Healthy Volunteers, Renal Impairment
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans.
- Trial name
- NCT02341599
- Testing
- MK-6183
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Chronic Kidney Disease, Chronic Renal Disease
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer.
- Trial name
- NCT00962000
- Testing
- Dialysis Flow Rate Start 600mL/min, Dialysis Flow Rate Start 800mL/min
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- Vantive Health LLC
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
Hyperphosphatemia, End-stage Renal Disease
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.
- Trial name
- NCT00648167
- Testing
- ferric citrate
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Keryx Biopharmaceuticals
Kidney Failure, Chronic, Renal Insufficiency, Chronic
A Study of LY2409021 in Participants With Different Levels of Kidney Function
The purpose of this study was to measure how much of the study drug, LY2409021, gets into the blood stream and how long it takes the body to get rid of it when given to participants with different levels of kidney function.
- Trial name
- NCT01929109
- Testing
- LY2409021
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
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
Chronic Kidney Disease
everlinQ endoAVF Post Market Study
Prospective, multi-center study to evaluate the everlinQ endoAVF System when used to create an endovascular arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
- Trial name
- NCT02682420
- Testing
- everlinQ endoAVF System
- Where
- 11 sites in Canada, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- C. R. Bard
End Stage Renal Disease
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via…
- Trial name
- NCT04042324
- Testing
- Triferic, Heparin
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Renal Impairment
Pharmacokinetics Of CP-690,550 In Patients With Impaired Renal Function
A study to evaluate the pharmacokinetics of CP-690,550 in subjects with mild, moderate or severe renal impairment, who do not require hemodialysis, compared to healthy controls.
- Trial name
- NCT01740362
- Testing
- CP-690,550
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease
Study to Assess the Safety and Pharmacokinetics of AKB-6548 in Participants With Chronic Kidney Disease (CKD), Stages 3 and 4
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
- Trial name
- NCT04707573
- Testing
- Vadadustat
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Akebia Therapeutics
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.
- Trial name
- NCT00509262
- Testing
- Sitagliptin, Glipizide
- Volunteers
- 426 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control
Primary Objective: To demonstrate the superiority of sotagliflozin 400 milligrams (mg) versus placebo with respect to hemoglobin A1c (HbA1c) reduction at Week 26 in participants with Type 2 diabetes who have inadequate glycemic…
- Trial name
- SOTA-CKD4 (NCT03242018)
- Testing
- Sotagliflozin
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 277 people
- Sponsor
- Lexicon Pharmaceuticals
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)
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
- Trial name
- NCT01704079
- Testing
- CTAP101 30 μg capsules, Sugar pill to CTAP101 30 μg capsules
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- OPKO IP Holdings II, Inc.
Chronic Kidney Disease (CKD)
Study of the Safety, Tolerability, and Pharmacokinetics of LHW090 in Patients With Moderately Impaired Renal Function
This was a randomized, double-blind, parallel group, placebo-controlled study, in two sequential parts that evaluated the renal safety, tolerability and pharmacokinetics of LHW090 in patients with moderately impaired renal…
- Trial name
- LHW090 (NCT02678000)
- Testing
- LHW090
- Where
- 12 sites in United States, Germany
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
Anaemia
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia…
- Trial name
- NCT01587898
- Testing
- GSK1278863
- Where
- 55 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
Metastatic Renal Cell Carcinoma
Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®.
- Trial name
- NCT00684645
- Testing
- SUTENT
- Where
- 20 sites in Czechia
- Volunteers
- 186 people
- Sponsor
- Pfizer