Clinical trials: Chronic Hemodialysis
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Kidney Diseases
Conversion From Standard Phosphate Binder Therapy to Fosrenol® (Lanthanum Carbonate) in Chronic Kidney Disease Stage 5
The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.
- Trial name
- NCT00452478
- Testing
- Lanthanum carbonate
- Where
- 14 sites in Austria, Belgium and 4 more
- Volunteers
- 68 people
- Sponsor
- Shire
End-stage Renal Disease (ESRD)
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.
- Trial name
- NCT02553889
- Testing
- ISIS 416858
- Where
- 8 sites in Canada
- Volunteers
- 49 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
End Stage Renal Disease (ESRD)
Automated Setting of Individualized Sodium Technology
The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients.
- Trial name
- ASIST (NCT02795286)
- Testing
- Artis Haemodialysis Machine w/ ASIST Software - Isonatremic, Artis Haemodialysis Machine w/ ASIST Software - Isotonic, Artis Haemodialysis Machine w/o ASIST Software
- Where
- Sweden
- Volunteers
- 18 people
- Sponsor
- Vantive Health LLC
Chronic Kidney Failure
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
- Trial name
- NCT00844662
- Testing
- Fermagate, Sevelamer hydrochloride
- Where
- 109 sites in United States, Belgium and 13 more
- Volunteers
- 1,000 people
- Sponsor
- Ineos Healthcare Limited
End-Stage Kidney Disease (ESKD)
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis
This study will evaluate three Investigational Medicinal Products (IMPs) called REGN9933, REGN7508, and REGN9533. The study is focused on participants with End-Stage Kidney Disease (ESKD) treated with hemodialysis and standard…
- Trial name
- NCT07759167
- Testing
- REGN9933, REGN7508, REGN9533
- Where
- Belgium
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Pruritus, Chronic Kidney Diseases
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
Rationale: People with long term kidney disease who are on haemodialysis (a procedure for removing waste products from the blood) commonly develop a condition that makes their skin very itchy.
- Trial name
- NCT06593392
- Testing
- Difelikefalin
- Where
- 18 sites in China, Greece and 5 more
- Volunteers
- 18 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma
Hyperparathyroidism, Secondary
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on…
- Trial name
- NCT02102204
- Testing
- Etelcalcetide
- Where
- 228 sites in United States, Australia and 22 more
- Volunteers
- 902 people
- Sponsor
- Amgen
End Stage Renal Disease, Hyperparathyroidism, Secondary
Mineral and Bone Disorders Outcomes in Stage 5D of Chronic Kidney Disease
The MBD-5D is a prospective observational study with a case-cohort and a cohort design. Eligible patients are receiving hemodialysis and have secondary hyperparathyroidism.
- Trial name
- MBD-5D (NCT00995163)
- Where
- Japan
- Volunteers
- 8,020 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Calciphylaxis
SEAPORT 1: Study of INZ-701 in Adults With Hemodialysis-Dependent End-Stage Kidney Disease
This Phase 1, open-label, multicenter study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of INZ-701 in adults with hemodialysis-dependent end-stage kidney disease (ESKD) and low plasma inorganic…
- Trial name
- SEAPORT 1 (NCT06283589)
- Testing
- INZ-701
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Inozyme Pharma
Chronic Kidney Disease, Renal Dialysis
A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.
- Conditions
- Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency
- Trial name
- NCT01017276
- Testing
- ASP1585
- Where
- 3 sites in Japan
- Volunteers
- 35 people
- Sponsor
- Astellas Pharma Inc
Chronic Renal Failure
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP…
- Trial name
- NCT01346215
- Testing
- heparin sodium
- Where
- Brazil
- Volunteers
- 132 people
- Sponsor
- Laboratório Químico Farmacêutico Bergamo Ltda.
Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
- Conditions
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance
- Trial name
- AL-EN-PHED (NCT01946841)
- Testing
- RealDiet®Renal
- Where
- France
- Sponsor
- Lactalis
Kidney Failure, Chronic
Pharmacokinetics and Safety of Alisporivir in Subjects With End Stage Renal Disease on Hemodialysis Compared to Healthy Subjects
The primary objective of the study was to compare the single dose pharmacokinetics of alisporivir in subjects with end stage renal disease (ESRD) on hemodialysis to those of matched healthy subjects.
- Trial name
- NCT01975337
- Testing
- Alisporivir
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Debiopharm International SA
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.
Renal Failure, End Stage Renal Disease
Development, Feasibility Testing and Validation of a Survey Set to Measure Patient-Reported Outcomes Among Hemodialysis Patients in Turkey
Development, feasibility testing and validation of a Survey Set to Measure Patient-Reported Outcomes among Hemodialysis Patients in Turkey: Creating and testing an electronic patient questionnaire that is suitable to measure…
- Trial name
- DOPRO (NCT05441020)
- Testing
- Administration of patient questionnaire
- Where
- 7 sites in Turkey (Türkiye)
- Volunteers
- 173 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Kidney Disease Patients
Metabolism and Excretory of HSK21542 in Maintenance Hemodialysis Patients
This is a single-center, nonrandomized, and open design study to investigate metabolism and excretion of HSK21542 in maintenance hemodialysis patients.
- Trial name
- NCT06238388
- Testing
- HSK21542 Injection
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Chronic Kidney Disease, Hemodialysis
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- Trial name
- DONATO (NCT01200784)
- Testing
- Nicotinamide
- Where
- 36 sites in Germany
- Volunteers
- 252 people
- Sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
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
End Stage Renal Disease, ESRD
Safety and Efficacy Assessments of NeoKidney® in ESRD Patients Treated With Short Daily Hemodialysis
The goal of this clinical investigation is to asses the safety and efficacy a new sorbent-based hemodialysis device, NeoKidney® in ESRD patients treated with short daily hemodialysis.
- Trial name
- FIH Caen (NCT06024135)
- Testing
- NeoKidney
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Nextkidney S.A.