Clinical trials: Chronic Kidney Disease Stage 1
End-stage Renal Failure
Safety and Dialysability of Dotarem® in Dialysed Patients
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
- Trial name
- NCT01449266
- Testing
- Dotarem® IV injection at 0.1 mmol/kg
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Guerbet
Hyperlipidemia, Mixed Dyslipidemia
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD)…
- Trial name
- NCT02275156
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Amgen
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)
The primary objective of the study is to assess the long term safety of treatment with tolvaptan in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).
- Trial name
- NCT02964273
- Testing
- Tolvaptan
- Where
- 20 sites in Belgium, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Kidney Disease
Phase 1 Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells in Chronic Kidney Disease
The goal of this clinical trial is to evaluate the safety of Cellgram-CKD in patients with chronic kidney disease over 12 months after three administrations.
- Trial name
- NCT05042206
- Testing
- Cellgram-CKD
- Where
- South Korea
- Volunteers
- 10 people
- Sponsor
- Pharmicell 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
Interstitial Lung Disease, Chronic Kidney Diseases
Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients With Interstitial Lung Disease or Chronic Kidney Disease
This is a Phase I, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of a 10 mg/kg dose of AD-214 when administered to healthy volunteers…
- Trial name
- NCT05914909
- Testing
- AD-214
- Where
- Australia
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- AdAlta Limited
Chronic Hepatitis C Infection
A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype…
- Trial name
- CORAL-I (NCT01782495)
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, ribavirin
- Volunteers
- 129 people
- Sponsor
- AbbVie
Anemia in Chronic Kidney Diseases
A Phase 1 Study of SSS17 in Healthy Subjects.
This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance…
- Trial name
- NCT04893187
- Testing
- SSS17
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
Kidney Disease, Renal Insufficiency Chronic
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to…
- Conditions
- Kidney Disease, Renal Insufficiency Chronic, Kidney Failure, Chronic, Renal Impairment
- Trial name
- NCT07426380
- Testing
- LY3841136
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Diabetic Kidney Disease, CAKUT
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
- Conditions
- Diabetic Kidney Disease, CAKUT, Chronic Kidney Diseases
- Trial name
- NCT05694169
- Testing
- Renal Autologous Cell Therapy (REACT)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Prokidney
Hyperplasia, Chronic Renal Failure
Prevention of Vascular Access Graft Failure in Patients With Chronic Renal Failure Requiring Hemodialysis
The purpose of this study is to determine the effect of recipient vein pretreatment of edifoligide (E2F Decoy), compared to placebo, on graft/recipient vein stenosis in polytetrafluoroethylene (PTFE) vascular access grafts placed…
- Trial name
- NCT00086164
- Testing
- edifoligide (E2F Decoy)
- Where
- 21 sites in United States
- Sponsor
- Anesiva, Inc.
Chronic Kidney Disease, Congenital Anomalies of Kidney and Urinary Tract
A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).
A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
- Trial name
- NCT04115345
- Testing
- Renal Autologous Cell Therapy (REACT)
- Where
- 5 sites in United States
- Volunteers
- 6 people
- Sponsor
- Prokidney
Hepatitis B
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤…
- Trial name
- NCT00426712
- Testing
- 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen, Hepatitis B Vaccine (Recombinant)
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Kidney Disease
Safety Study of GCS-100 to Treat Chronic Kidney Disease
The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease.
- Trial name
- NCT01717248
- Testing
- GCS-100
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- La Jolla Pharmaceutical Company
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
Renal Insufficiency
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
The purpose of this study is to determine the pharmacokinetic (how the drug concentrations change over time) profile of abiraterone acetate 1000 mg when administered as a single dose in male participants with impaired renal…
- Trial name
- NCT01715259
- Testing
- Abiraterone acetate: participants with end-stage renal disease, Abiraterone acetate: matched control participants with normal renal function
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cougar Biotechnology, Inc.
Anemia, Chronic Kidney Disease
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure, Cancer
- Trial name
- NCT00097747
- Testing
- peginesatide
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Affymax
End Stage Renal Disease
Plazomicin Study in ESRD Patients Receiving IHD
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD.
- Trial name
- NCT04699656
- Testing
- Plazomicin Injection
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Cipla USA Inc.