Clinical trials: Dialysis Patients
Anemia, Kidney Failure
Dynepo Infrequent Dosing Study
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and…
- Trial name
- NCT00450333
- Testing
- Dynepo (Epoetin delta), Dynepo
- Where
- 53 sites in Austria, Belgium and 5 more
- Volunteers
- 407 people
- Sponsor
- Shire
Anemia, Chronic Kidney Disease
Peginesatide for Anemia in Chronic Hemodialysis Patients
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure
- Trial name
- NCT00228449
- Testing
- peginesatide
- Where
- 14 sites in United States
- Volunteers
- 165 people
- Sponsor
- Affymax
Uremic Pruritus
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
- Trial name
- NCT03281538
- Testing
- CR845
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 288 people
- Sponsor
- Cara Therapeutics, Inc.
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism
The primary objective was to characterize corrected serum calcium levels on treatment with cinacalcet in pediatric patients with secondary hyperparathyroidism (HPT).
- Trial name
- NCT01439867
- Testing
- Cinacalcet hydrochloride, Standard of Care
- Where
- 42 sites in United States, Belgium and 11 more
- Volunteers
- 18 people
- Sponsor
- Amgen
Chronic Kidney Disease Requiring Chronic Dialysis
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients.
- Trial name
- NCT01324128
- Testing
- PA21 (2.5 g tablet containing 500 mg iron), Sevelamer carbonate, PA21-1 (1.25 g tablet containing 250 mg iron)
- Where
- 15 sites in United States, Austria and 13 more
- Volunteers
- 1,059 people
- Sponsor
- Vifor Pharma
Diabetes
Performance Evaluation of Lucie™ for Hydration of Dialysis Patients
The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure.
- Trial name
- PERF-LUCIE (NCT06640270)
- Testing
- Diabetes Treatment
- Volunteers
- 150 people
- Sponsor
- Home Habilis
Chronic Renal Failure, Anaemia
Study of Erythropoietin (EPO) Administration Schedule
The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.
- Trial name
- NCT01111630
- Testing
- recomon (Epoetin Beta)
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- JW Pharmaceutical
Hepatitis B
A Study to Compare the Immune Response and Safety Elicited by Henogen's Adjuvanted Hepatitis B Vaccine Compared to GSK Biologicals Adjuvanted Hepatitis B Vaccine in Pre-Dialysis and Dialysis Patients Who Have Not Been Exposed to Hepatitis B.
The pre-dialysis, peritoneal dialysis and haemodialysis patients would benefit from an improved hepatitis B vaccine, which will elicit stronger and faster cellular and humoral immune responses after the primary vaccination course.
- Trial name
- NCT00291941
- Testing
- Henogen HBV vaccine, FENDRIX
- Where
- 24 sites in Belgium, Czechia and 1 more
- Volunteers
- 300 people
- Sponsor
- Henogen
CKD Anemia in Stable Dialysis Patients
Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Participants With ESRD on Stable Dialysis
The primary objective of this study is to evaluate the efficacy and safety of roxadustat compared with active control (epoetin alfa) for the maintenance treatment of anemia in participants with ESRD on dialysis.
- Trial name
- NCT02273726
- Testing
- Epoetin Alfa, Roxadustat
- Where
- 76 sites in United States, Puerto Rico
- Volunteers
- 741 people
- Sponsor
- Kyntra Bio
Renal Dialysis
Study of Self-monitoring of Weight & Blood Pressure (Via patientMpower Platform) in Hemodialysis
Pilot-scale study to assess the effect of self-monitoring using the patientMpower electronic health journal (pMp app) [+digital weighing scales \& BP monitor] on outcomes in ambulatory haemodialysis patients.
- Trial name
- NCT03403491
- Testing
- patientMpower application
- Where
- Ireland
- Volunteers
- 43 people
- Sponsor
- patientMpower Ltd.
Chronic Kidney Disease, Renal Dialysis
Long-term Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.
- Conditions
- Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency, Hyperphosphatemia
- Trial name
- NCT00892749
- Testing
- ASP1585
- Where
- 4 sites in Japan
- Volunteers
- 248 people
- Sponsor
- Astellas Pharma Inc
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
Renal Anemia, Chronic
A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
This study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in participants with chronic kidney disease who are not on dialysis and not receiving…
- Trial name
- NCT00559273
- Testing
- Methoxy polyethylene glycol-epoetin beta, Darbepoetin alfa
- Where
- 76 sites in Australia, Belgium and 14 more
- Volunteers
- 307 people
- Sponsor
- Hoffmann-La Roche
Secondary Hyperparathyroidism
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
- Trial name
- BONAFIDE (NCT00261950)
- Testing
- Sensipar (Cinacalcet HCl)
- Where
- 55 sites in United States, Belgium and 10 more
- Volunteers
- 110 people
- Sponsor
- Amgen
Hepatic Encephalopathy, Liver Failure
Efficacy of Albumin Dialysis to Treat Patients With Hepatic Encephalopathy Using The Molecular Adsorbent Recirculating System (MARS)
The primary objective of the study was to compare the efficacy, safety and tolerability of Extracorporeal Albumin Dialysis (ECAD) using the Molecular Adsorbent Recirculating System (MARS®) device in improving severe HE by 2…
- Conditions
- Hepatic Encephalopathy, Liver Failure, Hepatitis, Chronic, Liver Cirrhosis
- Trial name
- NCT00287235
- Testing
- MARS, Standard Medical Therapy
- Where
- 8 sites in United States, Belgium and 1 more
- Volunteers
- 70 people
- Sponsor
- Vantive Health LLC
Chronic Kidney Disease, Secondary Hyperparathyroidism
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.
- Trial name
- NCT02138838
- Testing
- Cinacalcet HCl, Standard of Care
- Where
- 60 sites in United States, Belgium and 14 more
- Volunteers
- 55 people
- Sponsor
- Amgen
Anemia, Kidney Disease, Chronic
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12…
- Trial name
- ALTITUD (NCT01519947)
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 7 sites in Mexico
- Volunteers
- 87 people
- Sponsor
- Hoffmann-La Roche
End Stage Renal Disease, Hyperphosphatemia
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia
- Trial name
- NCT02469467
- Testing
- VS-505
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- KDL Inc.
Non-Dialysis-Dependent Chronic Kidney Disease
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With NDD-CKD
The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with…
- Trial name
- NCT03903809
- Testing
- Pegol-Sihematide, ESPO
- Where
- China
- Volunteers
- 175 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
END STAGE RENAL DISEASE
A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine
The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients.
- Trial name
- NCT01031966
- Testing
- MF59 adjuvanted H1N1 influenza monovalent vaccine, Thymosin alpha 1
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- sigma-tau i.f.r. S.p.A.