Clinical trials: Chronic Renal Failure
Secondary Hyperparathyroidism, Chronic Kidney Disease
A Trial of Etelcalcetide in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
This is a phase 3 trial of etelcalcetide in pediatric participants with secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) on hemodialysis.
- Trial name
- NCT03633708
- Testing
- Etelcalcetide, Standard of Care
- Where
- 43 sites in United States, Argentina and 8 more
- Volunteers
- 56 people
- Sponsor
- Amgen
Secondary Hyperparathyroidism, Chronic Kidney Disease
Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
- Trial name
- NCT02341417
- Testing
- Cinacalcet
- Where
- 33 sites in United States, Belgium and 9 more
- Volunteers
- 28 people
- Sponsor
- Amgen
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Kidney Disease, Chronic
An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)
This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice.
- Trial name
- NCT02547454
- Testing
- Methoxy polyethylene glycol-epoetin beta
- Where
- 12 sites in Slovenia
- Volunteers
- 393 people
- Sponsor
- Hoffmann-La Roche
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Chronic Kidney Disease Stage 5
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients. A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients…
- Trial name
- NCT01739660
- Testing
- Pegloticase
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Savient Pharmaceuticals
Secondary Hyperparathyroidism, End Stage Kidney Disease
Parathyroid Hormone (PTH) Attenuation Trial in Hemodialysis-2
This study is to evaluate the efficacy and safety of PLS240 in patients with hemodialysis-dependent end stage kidney disease (ESKD) and secondary hyperparathyroidism (SHPT). The study consists of two phases.
- Trial name
- PATH-2 (NCT05836220)
- Testing
- PLS240, Open-Label Extension PLS240
- Where
- 68 sites in United States, Bulgaria and 4 more
- Volunteers
- 412 people
- Sponsor
- Pathalys Pharma
Chronic Renal Failure
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or…
- Trial name
- NCT02331680
- Testing
- OPC-41061
- Where
- 4 sites in Japan
- Volunteers
- 124 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Magnetic Resonance Imaging, Chronic Kidney Diseases
Study of Polyglycan Superparamagnetic Ferric Oxide Injection on Cardiovascular Magnetic Resonance Imaging
Polysaccharide super paramagnetic ferric oxide injection is an iron supplement developed for patients with iron deficiency anemia. Due to its characteristics, it has the potential to be a contrast agent.
- Trial name
- NCT05687864
- Testing
- Polysaccharide superparamagnetic ferric oxide injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
End Stage Kidney Disease (ESRD)
STARgraft (10401) Pilot
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
- Trial name
- NCT07555717
- Testing
- STARgraft (10401)
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Healionics Corporation
CKD, ESRD
Long Term Hemodialysis Catheters (LTHD) Post Market Clinical Follow up (PMCF)
The primary objective of this observational PMCF study is to collect clinical data on the safety and efficacy of Medcomp Long Term Hemodialysis (LTHD) Catheter Kits in compliance with MDR 2017/745.
- Trial name
- LTHD PMCF (NCT04782297)
- Testing
- Long term hemodialysis catheter
- Where
- 2 sites in United States, Spain
- Sponsor
- Medical Components, Inc dba MedComp
Renal Impairment, Renal Disease
Study to Assess Adverse Events and the Movement of Oral Venetoclax Tablet Through the Body of Female Participants Aged 18-75 Years With Impaired Renal Function
Renal insufficiency is common in participants with blood cancers. The main objective of this study is to evaluate adverse events and movement of oral venetoclax tablets through the body of female participants with severe normal…
- Trial name
- NCT04810598
- Testing
- Venetoclax
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- AbbVie
End Stage Kidney Disease (ESRD)
Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1)
The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for…
- Trial name
- AMPLIFI-1 (NCT07211035)
- Testing
- The Amplifi System is a temporary extracorporeal blood pump designed to deliver controlled flow through a peripheral vein for 24-72 hours prior to AVF creation., Standard of Care (AVF creation)
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Amplifi Vascular, Inc.
CKD Anemia
REDCURE Registry for Chronic Kidney Disease (CKD) Anemia
A local registry on CKD-associated anemia aims to provide real-world insights into disease burden, treatment patterns, and outcomes at the national level.
- Trial name
- REDCURE (NCT07346547)
- Testing
- Daprodustat
- Volunteers
- 384 people
- Sponsor
- Nabiqasim Industries (Pvt) Ltd
Type 2 Diabetes Mellitus
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal…
- Trial name
- NCT02512068
- Testing
- Trelagliptin 25 mg
- Where
- 49 sites in Japan
- Volunteers
- 107 people
- Sponsor
- Takeda
Renal Dialysis
Multi-center Study to Investigate the Effects of Citrasate® on Heparin N Requirements During Hemodialysis Treatment
The purpose of this study is to determine whether the use of Citrasate®, citric acid dialysate enables the reduction of the heparin N (anticoagulant) dose in patients undergoing hemodialysis.
- Trial name
- NCT01092455
- Testing
- Heparin N reduction
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Randolph Quinn
Infectious Disease, Bacterial Infections
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal…
- Trial name
- NCT01746654
- Testing
- P128-0.1 mg, P128-0.3 mg, P128-1.0 mg
- Where
- Singapore
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GangaGen, Inc.
End Stage Renal Disease
Reveal LINQ™ Evaluation of Fluid
The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients.
- Trial name
- REEF (NCT02275923)
- Testing
- Reveal LINQ™ Insertable Cardiac Monitor
- Where
- Australia
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hyperphosphatemia, Chronic Kidney Disease
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced.
- Trial name
- OsvaRenNEW (NCT02027662)
- Testing
- Osvaren Granules, Osvaren film-coated tablets
- Where
- 11 sites in Germany
- Volunteers
- 61 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
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