Clinical trials: Complication of Dialysis
Uremic Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session.
- Trial name
- NCT03422653
- Testing
- CR845 0.5 mcg/kg
- Where
- 57 sites in United States
- Volunteers
- 378 people
- Sponsor
- Cara Therapeutics, Inc.
Pre-dialysis, End Stage Renal Disease
NESP Pediatric Study
Open-label, randomized study of NESP in pediatric subjects 18 years of age or younger. Subjects will receive study drug (NESP or rHuEPO) for 28 weeks after a 2 week screening and baseline period.
- Trial name
- NCT00527137
- Testing
- darbepoetin alfa, rHuEPO
- Volunteers
- 120 people
- Sponsor
- Amgen
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Iron Deficiency Anaemia, Iron Deficiency Anemia
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Trial name
- NCT02940860
- Testing
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Where
- 141 sites in United States
- Volunteers
- 1,538 people
- Sponsor
- Pharmacosmos A/S
Anemia, Renal Insufficiency, Chronic
Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
- Trial name
- DIALOGUE4 (NCT01975818)
- Testing
- Molidustat (BAY 85-3934), Epoetin alfa/beta
- Where
- 35 sites in United States, Japan
- Volunteers
- 201 people
- Sponsor
- Bayer
Anaemia
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)
The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.
- Trial name
- NCT03029208
- Testing
- Daprodustat, Darbepoetin alfa, Iron therapy
- Where
- 111 sites in United States, Argentina and 13 more
- Volunteers
- 312 people
- Sponsor
- GlaxoSmithKline
Kidney Failure, Chronic
A Study of LY3113593 in Healthy Participants and Participants With Chronic Kidney Disease Treated With Hemodialysis
The purpose of this study is to look at the tolerability and safety of LY3113593. Study doctors will see how safe it is and whether it produces side effects following a single injection into a vein or under the skin in healthy…
- Trial name
- NCT02144285
- Testing
- LY3113593
- Where
- 3 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Chronic Renal Failure
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous…
- Trial name
- NCT01895322
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis, ESRD (End-Stage Renal Disease), Dialysis
- Trial name
- RESPOND-2 (NCT06933472)
- Testing
- AP301, AP301 Low Dose
- Where
- 42 sites in United States, China
- Volunteers
- 264 people
- Sponsor
- Alebund Pharmaceuticals
Hyperphosphatemia, Chronic Kidney Disease
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
- Trial name
- SBR759 (NCT01069692)
- Testing
- SBR759A
- Where
- 9 sites in Belgium, Italy
- Volunteers
- 115 people
- Sponsor
- Novartis
ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD)
AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia
This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese…
- Conditions
- ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD), Hyperphosphatemia, Hyperphosphatemia in Chronic Kidney Disease
- Trial name
- RESPOND-1 (NCT07030595)
- Testing
- AP301, Sevelamer carbonate (Renvela®), AP301 Low Dose
- Where
- 50 sites in China
- Volunteers
- 474 people
- Sponsor
- Alebund Pharmaceuticals
Anemia, Renal Insufficiency, Chronic
Long Term Extension Study for the Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934
Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose.
- Trial name
- DIALOGUE5 (NCT02064426)
- Testing
- Molidustat (BAY85-3934), Epoetin alfa/beta
- Where
- 26 sites in United States, Japan
- Volunteers
- 88 people
- Sponsor
- Bayer
End Stage Renal Disease
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or…
- Trial name
- NCT00117104
- Testing
- Aranesp®
- Sponsor
- Amgen
Chronic Kidney Disease
Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers
The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device.
- Trial name
- NCT00636389
- Testing
- Polyflux 210H dialyzer, Polyflux HD-C4
- Where
- United States
- Volunteers
- 12 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
Anemia
Treatment of Anemia in Diabetic Subjects With CKD
The purpose of this study is to compare the proportion of subjects receiving either Epoetin alfa (PROCRIT®) or placebo who are able to achieve a hemoglobin response, defined by at least a 1 gram/deciliter increase from baseline…
- Trial name
- NCT00240734
- Testing
- Epoetin alfa
- Volunteers
- 11 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional…
- Conditions
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- Trial name
- NCT05124184
- Testing
- GORE® PROPATEN® Vascular Graft, GORE-TEX® Vascular Grafts
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 356 people
- Sponsor
- W.L.Gore & Associates
Dialysis Related Complication, Dehydration
Continuous Registration of Bioimpedance During Hemodialysis
This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.
- Trial name
- DELAGE (NCT03990818)
- Where
- Norway
- Volunteers
- 25 people
- Sponsor
- Mode Sensors AS
Anemia, Renal Insufficiency, Chronic
Maintenance Treatment of Renal Anemia in Dialysis Subjects
The purpose of this study is to evaluate the efficacy and safety of molidustat in comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).
- Trial name
- MIYABI HD-M (NCT03543657)
- Testing
- Molidustat (BAY85-3934), Darbepoetin alfa
- Where
- 53 sites in Japan
- Volunteers
- 229 people
- Sponsor
- Bayer
Anemia of Chronic Kidney Disease
Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
Phase III, multicenter, randomized, open, controlled clinical trial. A study designed as phase III, in 120 patients with chronic renal failure in the pre-dialysis stage, evaluate efficacy and safety of Hemax PFS® (PFS: prefilled…
- Trial name
- NCT04036253
- Testing
- Erythropoietin alfa
- Where
- 11 sites in Argentina, Paraguay
- Volunteers
- 43 people
- Sponsor
- Bio Sidus SA