Clinical trials: End Stage Renal Disease
End Stage Renal Disease on Hemodialysis
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis
This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects.
- Trial name
- NCT05885763
- Testing
- Difelikefalin Injection
- Where
- 4 sites in China
- Volunteers
- 30 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Kidney Disease
Safety Evaluation of Use Sodic Enoxaparin
The purpose of this study was to evaluate safety, not inferiority clinical and pharmacodynamic profile of the drug Enoxaparin Sodium produced by laboratory Blausiegel when compared with Clexane product, produced by Laboratory…
- Trial name
- Enoxaparin (NCT00673426)
- Testing
- Enoxaparin sodic
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Azidus Brasil
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
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
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
Renal Insufficiency
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal…
- Trial name
- NCT01715259
- Testing
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Secondary Hyperparathyroidism, End Stage Renal Disease
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.
- Trial name
- NCT00053547
- Testing
- paricalcitol injection
- Where
- 6 sites in United States
- Volunteers
- 28 people
- Sponsor
- Abbott
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
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 Stage 5 on Dialysis
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients
A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of anemia in patients with CKD on dialysis. (DREAM-D)
- Trial name
- DREAM-D (NCT04215120)
- Testing
- Desidustat Oral Tablet, Epoetin Alfa
- Where
- 7 sites in India
- Volunteers
- 392 people
- Sponsor
- Zydus Lifesciences Limited
Chronic Kidney Failure
Efficacy and Safety Study of Magnesium Iron Hydroxycarbonate for the Reduction of High Blood Phosphate in Hemodialysis Patients
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00317694
- Testing
- Fermagate
- Where
- 15 sites in United States, United Kingdom
- Volunteers
- 111 people
- Sponsor
- Ineos Healthcare Limited
Staphylococcal Skin Infections, Streptococcal Infections
Pharmacokinetic Study,Ceftobiprole,Healthy Volunteers,Healthy Patients With End Stage Renal Disease
The purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single…
- Trial name
- NCT01030731
- Testing
- Ceftobiprole
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
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
Hyperphosphatemia
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
- Trial name
- NCT06664125
- Testing
- JMKX003002 will be administered orally, Sevelamer carbonate
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Jemincare
Healthy
Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension
To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment
- Trial name
- NCT00637403
- Testing
- Megestrol acetate concentrated suspension 125 mg/mL
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
End Stage Renal Disease
Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft.
- Trial name
- AdV-VANTAGE (NCT00895479)
- Testing
- Graft placement surgery plus Trinam therapy
- Where
- 12 sites in United States
- Volunteers
- 250 people
- Sponsor
- Ark Therapeutics Ltd
Anemia of Chronic Disease
A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD
The trial is an uncontrolled, open-label, parallel group clinical trial. Approximately 10 subjects per dose group in 3 groups will be treated twice weekly for a total of 9 doses, followed by a 4-week observation period.
- Trial name
- NCT01873534
- Testing
- FMX-8
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- FerruMax Pharmaceuticals, Inc.
End Stage Renal Disease, Inflammation
Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers
The study is a prospective cohort trial utilizing sequential laboratory results from excess serum obtained from hemodialysis patients (acting as their own controls).
- Trial name
- NCT00440908
- Where
- 2 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Fresenius Medical Care North America