Clinical trials: End-stage Disease
Renal Dialysis
End-stage Renal Disease (ESRD) Pilot Study
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD).
- Trial name
- NCT03787368
- Testing
- BAY1213790, 0.9% sodium chloride solution
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 55 people
- Sponsor
- Bayer
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
End-stage Renal Disease, Kidney Failure, Chronic
Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01744418
- Testing
- HAVG graft implantation
- Where
- 3 sites in Poland
- Volunteers
- 40 people
- Sponsor
- Humacyte, Inc.
Heart Failure, Heart Failure At NYHA Stage III or IV
IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure
This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in…
- Trial name
- NCT06866600
- Testing
- low dose CABG+iPSC-CMs, High dose CABG/LVAD+iPSC-CMs, CABG/LVAD+Saline
- Where
- China
- Volunteers
- 40 people
- Sponsor
- HELP Therapeutics Co., Ltd.
End-Stage Renal Disease
Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)
This study is to examine the safety of daptomycin in patients with End Stage Renal Disease.
- Trial name
- NCT00490737
- Testing
- daptomycin
- Volunteers
- 12 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Type 2 Diabetes Mellitus
Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease"
The purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.
- Trial name
- NCT04285983
- Testing
- Trelagliptin
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Takeda
OTOF Gene Mutation, DFNB9
A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations
This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.
- Conditions
- OTOF Gene Mutation, DFNB9, Congenital Deafness, Hearing Disorders
- Trial name
- AUDIOGENE (NCT06370351)
- Testing
- SENS-501 administration
- Where
- 2 sites in Australia, France
- Volunteers
- 12 people
- Sponsor
- Sensorion
End-Stage Renal Disease
Cook Enforcer Post-Market Study
The purpose of this study is to evaluate the performance of the Cook Advance® Enforcer™ 35 Focal-Force PTA Balloon Catheter (or Enforcer balloon) in treating narrowed blood vessels compared to treatment with a conventional…
- Trial name
- NCT03552289
- Testing
- Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, Conventional angioplasty balloon catheters
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- Cook Research Incorporated
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.
End-stage Renal Disease, Malnutrition; Protein
Impact of IDPN on Nutrition Markers in Patients Receiving ICHD
Evaluate the impact of intradialytic parenteral nutrition (IDPN) compounded with Clinisol, Prosol, and/or Clinolipid on albumin levels and weight in patients with end-stage renal disease (ESRD) undergoing in-center hemodialysis.
- Trial name
- NCT05439174
- Testing
- Intradialytic Parenteral Nutrition
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Patient Care America
Peritoneal Dialysis-associated Peritonitis, End Stage Renal Disease
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.
- Trial name
- NCT05300191
- Testing
- Effluent dialysate
- Where
- Mexico
- Volunteers
- 500 people
- Sponsor
- CloudCath
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
End Stage Renal Disease
A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD).
- Trial name
- NCT02617784
- Testing
- Oseltamivir
- Where
- New Zealand
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Renal Disease, End-Stage, Renal Insufficiency, Chronic
Bosutinib In Subjects With Renal Impairment
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers.
- Conditions
- Renal Disease, End-Stage, Renal Insufficiency, Chronic, Renal Insufficiency, Acute
- Trial name
- NCT01233882
- Testing
- Bosutinib
- Where
- 5 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer
Anemia in Incident Dialysis Patients
Safety and Efficacy Study of Roxadustat (FG-4592) for the Treatment of Anemia in End-Stage Renal Disease (ESRD) Newly Initiated Dialysis Participants
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants who have just begun dialysis treatment for ESRD.
- Trial name
- Himalayas (NCT02052310)
- Testing
- Roxadustat, Epoetin Alfa
- Where
- 113 sites in United States, Argentina and 13 more
- Volunteers
- 1,043 people
- Sponsor
- Kyntra Bio
Uremic Pruritus
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
This study is being conducted to investigate the efficacy of MT-9938 compared with placebo after 2 weeks, to continue to evaluate efficacy for an additional 6 weeks, and to explore the effect of a reduction in itching intensity…
- Trial name
- NCT01660243
- Testing
- Nalfurafine hydrochloride(MT-9938) 2.5μg, Nalfurafine hydrochloride(MT-9938) 5μg, Nalfurafine hydrochloride(MT-9938) 10μg
- Where
- 4 sites in United States
- Volunteers
- 45 people
- Sponsor
- Toray Industries, Inc
Chronic Kidney Disease, End-Stage Renal Disease
Pharmacokinetics of Somatropin in Patients With End Stage Renal Disease Receiving Chronic Haemodialysis
This trial is conducted in Europe. The aim of this trial is to to compare steady-state total growth hormone (GH) exposure in haemodialysis (HD) patients with that of matched healthy subjects.
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease, Healthy
- Trial name
- NCT01502137
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- Novo Nordisk A/S
Renal Failure, End Stage Renal Disease
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler which are both…
- Trial name
- NCT04749680
- Testing
- PD cycler Silencia
- Where
- 4 sites in Chile
- Volunteers
- 16 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
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.
End Stage Renal Disease
New Needle for Two-Needle Hemodialysis
Our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the…
- Trial name
- BME-1 (NCT01416896)
- Testing
- Hemodialysis using the standard venous needle, Hemodialysis using a new venous needle, the "BME needle"
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Biomedical Enterprises Inc