Clinical trials: Hemodialysis
Malnutrition, Complication of Hemodialysis
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
- Trial name
- IDPNHD (NCT00501956)
- Testing
- Intradialytic Parenteral Nutrition (IDPN)
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Fresenius Kabi
Anemia Associated With Chronic Kidney Disease
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
This study will be conducted to assess the pharmacokinetics of vadadustat 600, 750, and 900 milligrams daily, and intravenous erythropoiesis-stimulating agent (darbepoetin alfa or epoetin alfa), in hemodialysis participants with…
- Trial name
- NCT03992066
- Testing
- Vadadustat, Darbepoetin alfa, Epoetin alfa
- Where
- 10 sites in United States
- Volunteers
- 46 people
- Sponsor
- Akebia Therapeutics
Hemodialysis Complication
UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured…
- Trial name
- HEPIRC (NCT05148377)
- Testing
- Liquaemin, Heptar
- Volunteers
- 128 people
- Sponsor
- Eurofarma Laboratorios S.A.
Chronic Renal Failure Requiring Hemodialysis
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients…
- Trial name
- AiME - 03 (NCT01628107)
- Testing
- Epoetin Hospira
- Where
- 110 sites in United States, Puerto Rico
- Volunteers
- 406 people
- Sponsor
- Pfizer
Acute Lung Injury, Acute Kidney Injury
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal…
- Conditions
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
- Trial name
- multiECCO2R (NCT04871893)
- Testing
- multiECCO2R blood-gas exchanger
- Where
- 6 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Kidney Failure, Chronic, Hemodialysis Complication
The Pristine Post-Market Study
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
- Conditions
- Kidney Failure, Chronic, Hemodialysis Complication, Hemodialysis Catheter Infection, Hemodialysis Access Failure
- Trial name
- NCT05228132
- Testing
- Pristine™ Long-Term Hemodialysis Catheter
- Where
- 6 sites in United States
- Volunteers
- 142 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease Stage 5
Quality of Life and Depression in Dialysis Patients
The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and depression over time.
- Trial name
- QOLD (NCT01668628)
- Where
- South Korea
- Volunteers
- 1,068 people
- Sponsor
- Fresenius Medical Care Korea
Anemia
A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on…
- Trial name
- NCT00717821
- Testing
- Methoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta, Darbepoetin Alfa
- Where
- 89 sites in France
- Volunteers
- 421 people
- Sponsor
- Hoffmann-La Roche
End-stage Renal Disease (ESRD)
A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS 416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI activity reduction.
- Trial name
- EMERALD (NCT03358030)
- Testing
- ISIS 416858
- Where
- 2 sites in Spain
- Volunteers
- 213 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hepatitis B
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10…
- Trial name
- NCT00383591
- Testing
- Hepatitis B adjuvanted vaccine, Engerix-B
- Where
- 5 sites in Czechia, Malaysia and 1 more
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Kidney Diseases, Renal Insufficiency
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.
- Trial name
- NCT00358046
- Testing
- ILY101
- Where
- 18 sites in United States
- Volunteers
- 120 people
- Sponsor
- Ilypsa
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05342623
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 83 sites in United States
- Volunteers
- 286 people
- Sponsor
- Cara Therapeutics, Inc.
End-Stage Renal Disease Requiring Haemodialysis
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients
The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis.
- Trial name
- NCT07201467
- Testing
- KN060
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Pruritus
A Study of SHR0410 in Hemodialysis Patients With Pruritus
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
- Trial name
- NCT04317209
- Testing
- SHR0410
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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.
Anemia
A Study of Intravenous Mircera (C.E.R.A or Methoxy Polyethylene Glycol-epoetin Beta) for the Maintenance Treatment of Hemodialysis Participants With Chronic Renal Anemia
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous (IV) Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia.
- Trial name
- NCT00605293
- Testing
- methoxy polyethylene glycol-epoetin beta, Epoetin alfa
- Where
- 19 sites in Spain
- Volunteers
- 101 people
- Sponsor
- Hoffmann-La Roche
Renal Failure Chronic Requiring Hemodialysis
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD)…
- Trial name
- NCT01322347
- Testing
- Soluble Ferric Pyrophosphate (SFP), Standard dialysate
- Where
- 40 sites in United States, Canada
- Volunteers
- 294 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
Anemia
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
- Trial name
- NCT00224003
- Testing
- Sodium Ferric Gluconate Complex in Sucrose.
- Where
- 10 sites in United States
- Volunteers
- 23 people
- Sponsor
- Watson Pharmaceuticals
Anemia
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis.
- Trial name
- NCT01667380
- Where
- Montenegro
- Volunteers
- 78 people
- Sponsor
- Hoffmann-La Roche