Clinical trials: End Stage Disease
Chronic Kidney Disease, End Stage Renal Disease
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease
The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Anemia
- Trial name
- NCT01630889
- Testing
- Roxadustat
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 15 people
- Sponsor
- Kyntra Bio
Chronic Renal Failure, Anemia
Safety & Efficacy of EPO-018B for the Treatment of Anemia in Participants With ERSD Receiving Maintenance Hemodialysis
The purpose of this study is to evaluate the safety,efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of EPO-018B in participants with chronic kidney disease (CKD) who are on hemodialysis.
- Trial name
- NCT02366325
- Testing
- EPO-018B
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
End Stage Renal Disease, Renal Transplant
Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection
Induction therapy with antibodies is administered during transplant surgery and for a short period of time following transplant surgery in an effort to render the immune system less able to mount an initial rejection response.
- Trial name
- NCT01154387
- Testing
- Anti-Thymocyte Globulin, TOL101, Steroids
- Where
- 12 sites in United States
- Volunteers
- 85 people
- Sponsor
- Tolera Therapeutics, Inc
End-Stage Kidney Disease
Evaluate the Survival Benefits of Zemplar Versus Calcijex in Subjects w/ Stage V Chronic Kidney Disease on Hemodialysis
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to…
- Trial name
- NCT00062699
- Testing
- Zemplar (paricalcitol injection), Calcijex
- Where
- 60 sites in United States
- Volunteers
- 2,200 people
- Sponsor
- Abbott
SARS-CoV-2 Infection (Asymptomatic), SARS-CoV-2 Infection (Symptomatic)
COVID-19 Progression in End-Stage Kidney Disease
The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.
- Trial name
- COPE (NCT04495907)
- Where
- 11 sites in United States
- Volunteers
- 412 people
- Sponsor
- Davita Clinical Research
End Stage Renal Disease
Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line
- Trial name
- NCT03303144
- Testing
- Triferic
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Hepatic Encephalopathy
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
- Trial name
- EMMPOWER (NCT04816916)
- Testing
- AXA1665
- Where
- 40 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Axcella Health, Inc
HIV Infections
A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP).
- Trial name
- EBONI (NCT05514509)
- Testing
- APRETUDE, Cabotegravir tablet
- Where
- 22 sites in United States
- Volunteers
- 295 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Infections, Bacterial
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
This study will be conducted to determine if altered renal function affects the plasma pharmacokinetics of gepotidacin, which will inform if dosing recommendations based upon renal impairment are required.
- Trial name
- NCT02729038
- Testing
- Gepotidacin
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 2, Diabetic Nephropathy
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage…
- Trial name
- CREDENCE (NCT02065791)
- Testing
- Canagliflozin
- Where
- 575 sites in United States, Argentina and 32 more
- Volunteers
- 4,401 people
- Sponsor
- Janssen Research & Development, LLC
Hereditary Angioedema, HAE
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related…
- Conditions
- Hereditary Angioedema, HAE, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2
- Trial name
- STOP-HAE (NCT06960213)
- Testing
- ADX-324
- Where
- 70 sites in United States, Argentina and 22 more
- Volunteers
- 90 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Acute Transplant Rejection in Patients Receiving Allogeneic Renal Transplant
Generic Mycophenolate Mofetil Safety Study for Prophylaxis in de Novo Renal Transplant Patients in Jordan
The purpose of this observational study was to assess the safety and efficacy of generic mycophenolate mofetil in de novo renal transplant patients in Jordan where no visits or intervention(s) additional to the daily practice…
- Trial name
- MyOra-PASS (NCT03517982)
- Testing
- Mycophenolate Mofetil
- Where
- Jordan
- Volunteers
- 12 people
- Sponsor
- Hikma Pharmaceuticals LLC
End Stage Renal Disease
The EvAluation of TaBlo In-CLinic and In-HOme
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.
- Trial name
- TABLO (NCT02460263)
- Testing
- Tablo Hemodialysis System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Outset Medical
Kidney Disease, End-Stage
PATH-03 Paraguay Feasibility Study
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
- Trial name
- NCT07034092
- Testing
- ePATH System will be used to create an endoAVF
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Pathfinder Medical
Primary IgA Nephropathy
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal…
- Trial name
- Nefigard (NCT03643965)
- Testing
- Nefecon
- Where
- 142 sites in United States, Argentina and 17 more
- Volunteers
- 365 people
- Sponsor
- Calliditas Therapeutics AB
Renal Impairment
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
- Trial name
- NCT07559396
- Testing
- INCB123667
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Incyte Corporation
Chronic Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
The incidence of efficacy failure at 12 months between two regimens.
- Conditions
- Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
- Trial name
- NCT00044720
- Testing
- Rapamune
- Volunteers
- 484 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplant Rejection, End Stage Renal Disease
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients.
- Trial name
- STEADFAST (NCT04817774)
- Testing
- TX200-TR101
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Sangamo Therapeutics
End Stage Renal Disease
Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients
The FAST Plasma Volume (PV) Technology will aid in determining the plasma and interstitial volumes of end stage renal disease patients before and after dialysis therapy, providing a more precise understanding of pre and post…
- Trial name
- NCT04733664
- Testing
- VFI using the FAST PV Technology
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- FAST BioMedical
Hepatitis C Virus (HCV)
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment…
- Trial name
- NCT02487199
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir
- Volunteers
- 18 people
- Sponsor
- AbbVie