Clinical trials: Renal Dysfunction
Chronic Renal Failure, Chronic Kidney Disease
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- EMERALD 2 (NCT00597584)
- Testing
- peginesatide, Epoetin alfa or Epoetin beta
- Where
- 84 sites in United States, Bulgaria and 7 more
- Volunteers
- 823 people
- Sponsor
- Affymax
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Type 2 Diabetes Mellitus
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.
- Trial name
- NCT01512849
- Testing
- TA-7284 Low, TA-7284 High
- Where
- Japan
- Volunteers
- 24 people
- Sponsor
- Tanabe Pharma Corporation
Hypertension With Renal Dysfunction
Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
- Trial name
- NCT01593787
- Testing
- LCZ696
- Where
- 13 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Anaemia
Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of anaemia associated with chronic kidney disease…
- Trial name
- NCT02243306
- Testing
- GSK1278863
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Chronic Kidney Disease, Type 1 Diabetes Mellitus
A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes.
- Trial name
- FINE-ONE (NCT05901831)
- Testing
- Finerenone
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 242 people
- Sponsor
- Bayer
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment
This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection…
- Trial name
- EXPEDITION-5 (NCT03069365)
- Testing
- Glecaprevir/pibrentasvir
- Where
- 38 sites in United States, Canada and 8 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Hyperphosphatemia, Chronic Kidney Disease
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was…
- Trial name
- NCT01039428
- Testing
- HS219
- Where
- 11 sites in Japan
- Volunteers
- 68 people
- Sponsor
- KDL Inc.
Renal Impairment
A Renal Impairment Study for PF-06651600
This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment…
- Trial name
- NCT04037865
- Testing
- PF-06651600
- Where
- 3 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Failure, Tremors
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro.
- Trial name
- STRATO (NCT01438710)
- Testing
- Prograf, LCP-Tacro
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Veloxis Pharmaceuticals
Iron Deficiency Anemia, Iron Deficiency Anaemia
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
- Trial name
- FERWON-EXT (NCT02962648)
- Testing
- Iron isomaltoside/ferric derisomaltose
- Where
- 22 sites in United States
- Volunteers
- 103 people
- Sponsor
- Pharmacosmos A/S
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Anaemia
A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)
Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese…
- Trial name
- NCT02969655
- Testing
- Daprodustat small, Daprodustat large, Darbepoetin alfa
- Where
- 50 sites in Japan
- Volunteers
- 271 people
- Sponsor
- GlaxoSmithKline
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
Kidney Disease, Chronic
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice.
- Trial name
- NCT02547454
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 12 sites in Slovenia
- Volunteers
- 393 people
- Sponsor
- Hoffmann-La Roche
Osteoporosis
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage…
- Trial name
- NCT01833754
- Testing
- Romosozumab
- Where
- 5 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatitis C
Pharmacokinetic and Safety Study of Daclatasvir in Patients With Renal Impairment
The purpose of this study is to assess the effect of renal function impairment on the single dose pharmacokinetics of Daclatasvir.
- Trial name
- NCT01830205
- Testing
- Daclatasvir
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
End Stage Renal Disease (ESRD)
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of…
- Trial name
- NCT01343251
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Merit Medical Systems, Inc.
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