Clinical trials: Haemodialysis
Hyperphosphatemia Patients on Hemodialysis
A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis
- Trial name
- NCT06745518
- Testing
- TS-172
- Where
- Japan
- Volunteers
- 62 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Dialysis, Chronic Renal Failure
A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
- Trial name
- HEMO (NCT04655989)
- Testing
- DBB-EXA ES Hemodialysis System
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- Nikkiso America, 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
Hyperphosphatemia, End Stage Renal Disease
Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis
To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis
- Conditions
- Hyperphosphatemia, End Stage Renal Disease, ESRD
- Trial name
- NCT03984760
- Testing
- Ferric Citrate, Sevelamer Carbonate
- Where
- 24 sites in China
- Volunteers
- 240 people
- Sponsor
- Panion & BF Biotech Inc.
Uremic Pruritus
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients…
- Trial name
- NCT05031546
- Testing
- Difelikefalin
- Sponsor
- Cara Therapeutics, Inc.
Uremic Pruritus, Pruritus
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
- Trial name
- NCT02143973
- Testing
- nalbuphine HCl ER
- Where
- 35 sites in United States
- Volunteers
- 167 people
- Sponsor
- Trevi Therapeutics
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
Anemia of Chronic Kidney Disease
Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Study to evaluate the effect of lapatinib, a breast cancer resistance protein (BCRP) inhibitor, on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety and tolerability of JTZ-951 when administered alone and one hour…
- Trial name
- NCT02581124
- Testing
- JTZ-951, Lapatinib
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Shionogi Inc.
Dialysis Access Malfunction
Continued Access Study VIG Anastomotic Connector
The continued access study of the InterGraft Venous Anastomotic Connector (Venous InterGraft Continued Access Study, or 'VIG-CAS') allows for continued enrollment of subjects while the marketing application is being prepared and…
- Trial name
- VIG-CAS (NCT05448950)
- Testing
- VIG Continued Access Study
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Phraxis, Inc.
Hyperkalemia, Hemodialysis
Hyperkalaemia Prevalence, Recurrence and Treatment in Haemodialysis
The objective of this study is to evaluate the prevalence and recurrence of Hyperkalaemia (HK) in Chinese HD patients and to understand the treatment pattern of HK in China.
- Conditions
- Hyperkalemia, Hemodialysis, Water-Electrolyte Imbalance
- Trial name
- PRECEDE-K (NCT04799067)
- Testing
- observational study
- Where
- 12 sites in China
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Renal Failure Chronic Requiring Hemodialysis
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
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
- CRUISE 1 (NCT01320202)
- Testing
- Soluble Ferric Pyrophosphate (SFP), Standard dialysate
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 305 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Malnutrition
DaVita Assessment of Nutritional Supplement Effects (DANSE)
This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients.
- Trial name
- DANSE (NCT00895401)
- Testing
- Nepro with Carb Steady, Standard of Care
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Davita Clinical Research
Uremic Pruritus
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
- Trial name
- NCT03998163
- Testing
- CR845 0.5 mcg/kg
- Where
- 47 sites in United States, Czechia and 2 more
- Volunteers
- 222 people
- Sponsor
- Cara Therapeutics, Inc.
Anemia in Chronic Kidney Disease
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis
- Trial name
- NCT01978587
- Testing
- JTZ-951
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shionogi Inc.
Secondary Hyperparathyroidism, Chronic Kidney Disease
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with…
- Trial name
- NCT01896232
- Testing
- Etelcalcetide, Cinacalcet
- Where
- 182 sites in United States, Austria and 20 more
- Volunteers
- 683 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.
- Trial name
- NCT06877247
- Testing
- [14C] SHR6508 Injection
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Secondary Hyperparathyroidism
Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney…
- Trial name
- NCT01414114
- Testing
- Etelcalcetide
- Volunteers
- 37 people
- Sponsor
- KAI Pharmaceuticals
ESRD
Influence of the PEPA Membrane on the Undernutrition Syndrome Inflammation in Chronic Hemodialysis
NutriPEPA2 is a randomized, single-blind, prospective, multicenter trial, in two parallel arms to confirm that the adsorbent PEPA membrane may decrease mortality related to inflammation and malnutrition encountered in HD or…
- Trial name
- NutriPEPA2 (NCT04185571)
- Testing
- PEPA
- Where
- 12 sites in France, Monaco
- Volunteers
- 106 people
- Sponsor
- Theradial
Chronic Kidney Diseases, Pruritus
A Study to Evaluate the Safety and Efficacy of CR845 in 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 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD)…
- Trial name
- NCT03617536
- Testing
- CR845 0.25 mg Oral Tablet, CR845 0.5 mg Oral Tablet, CR845 1 mg Oral Tablet
- Where
- 60 sites in United States
- Volunteers
- 269 people
- Sponsor
- Cara Therapeutics, Inc.
Secondary Hyperparathyroidism
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic…
- Trial name
- NCT00463021
- Testing
- Hectorol (doxercalciferol capsules), Zemplar (paricalcitol injection)
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- Genzyme, a Sanofi Company