Clinical trials: Complication of Dialysis
Hemodialysis, Healthy
Study to Evaluate the Pharmacokinetics and Metabolism of [14C] CR845 (Difelikefalin) in Patients With End Stage Renal Disease on Hemodialysis and in Healthy Subjects
The objectives of this study are to evaluate the in vivo metabolite profiling and characterization of CR845 administered intravenously (IV) in patients on hemodialysis (HD) and in healthy subjects; and to determine the…
- Trial name
- NCT03947970
- Testing
- [14C] CR845
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Disease, Hyperphosphatemia
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries.
- Trial name
- ASPIRE (NCT00833768)
- Testing
- Sevelamer carbonate
- Where
- 36 sites in Austria, France and 7 more
- Volunteers
- 5 people
- Sponsor
- Genzyme, a Sanofi Company
Renal Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of…
- Trial name
- NCT03296787
- Testing
- TAK-954
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
End Stage Renal Disease, Continuous Ambulatory Peritoneal Dialysis
Open-label, Randomized Trial to Determine the Effect of Icodextrin Versus Dextrose (Dianeal 2.5%) in HOMA IR
Phase IV post-marketing study to evaluate the effect of Extraneal on the HOMA index in non-diabetic CAPD patients over the long-dwell exchange.
- Trial name
- ECOS (NCT01093547)
- Testing
- Blood samples, Measure of peritoneal ultrafiltrates
- Where
- Colombia
- Sponsor
- Vantive Health LLC
Malnutrition, ESRD
ProStat Supplementation in Dialysis Patients
This is a long-term, randomized, placebo-controlled, double blind clinical study of a nutritional supplement, ProStat 64, in chronic hemodialysis patients with poor nutrition.
- Trial name
- NCT00435123
- Testing
- Nutritional Supplement ProStat 64 twice a day
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care North America
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
End Stage Renal Disease
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
- Trial name
- NCT02378350
- Testing
- Hemodialysis treatment (no specific device is defined), Peritoneal Dialysis treatment (no specific drug is defined)
- Where
- 21 sites in China
- Volunteers
- 668 people
- Sponsor
- Vantive Health LLC
End Stage Renal Disease
A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis
To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on…
- Trial name
- NCT00646035
- Testing
- paricalcitol capsules
- Where
- 24 sites in United States, Poland
- Volunteers
- 75 people
- Sponsor
- Abbott
Renal Impairment
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment
The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.
- Trial name
- NCT06318676
- Testing
- Mezigdomide
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
End Stage Renal Disease
Triferic Pediatric Pharmacokinetic Protocol
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD).
- Trial name
- NCT02595437
- Testing
- Triferic
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Chronic Kidney Disease
EPO Deep Tank in Dialysis Subjects
Subject incidence of adverse events
- Trial name
- NCT00156949
- Testing
- Epoetin alfa DT
- Volunteers
- 580 people
- Sponsor
- Amgen
Anemia
Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were…
- Trial name
- NCT00752609
- Testing
- Peginesatide
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Takeda
End Stage Renal Disease, End Stage Renal Disease on Dialysis
First Evaluation of the Moda-Flx Hemodialysis System™ in Real World Clinical Settings
This is a non-significant risk study utilizing a device cleared for use by the FDA under its 510(k) clearance. Consented patients will complete their usual dialysis treatment under professional care in an ICHD (In-Center…
- Conditions
- End Stage Renal Disease, End Stage Renal Disease on Dialysis, End Stage Kidney Disease
- Trial name
- NCT06581393
- Testing
- Moda-flx Hemodialysis System
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Diality Inc.
Anaemia
Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia
This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50…
- Trial name
- NCT02791763
- Testing
- 1 to 4 mg tablets of GSK1278863, 6 mg GSK1278863 tablet, Epoetin beta pegol
- Where
- 56 sites in Japan
- Volunteers
- 355 people
- Sponsor
- GlaxoSmithKline
End-Stage Renal Disease
L-Carnitine in Peritoneal Dialysis
The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy.
- Trial name
- NCT00922701
- Testing
- L-carnitine
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Iperboreal Pharma Srl
Chronic Kidney Disease
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein.
- Trial name
- PRT-201-102 (NCT01001351)
- Testing
- PRT-201
- Where
- 16 sites in United States
- Volunteers
- 89 people
- Sponsor
- Proteon Therapeutics
Diabetes Mellitus, Type 2, End-Stage Kidney Disease
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1)
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.
- Trial name
- NCT00509236
- Testing
- Sitagliptin, Glipizide
- Volunteers
- 129 people
- Sponsor
- Merck Sharp & Dohme LLC
Anemia of Chronic Kidney Disease
PBF-1681 (Ferric Citrate) for the Treatment of IDA in Patients With NDD-CKD
To assess the safety and effectiveness of PBF-1681 for the treatment of Iron Deficiency Anemia in patients with Non-Dialysis Dependent Chronic Kidney Disease.
- Trial name
- NCT04543812
- Testing
- Ferric citrate
- Where
- 12 sites in Taiwan
- Volunteers
- 141 people
- Sponsor
- Panion & BF Biotech Inc.
Chronic Kidney Disease, Hyperphosphatemia
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis
The purpose of this study is to summarize the percentage of participants achieving age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus in hyperphosphatemic children and adolescents with…
- Trial name
- NCT01696279
- Testing
- Lanthanum Carbonate, Calcium Carbonate
- Where
- 22 sites in Argentina, Chile and 7 more
- Volunteers
- 63 people
- Sponsor
- Shire
End Stage Renal Disease, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis