Clinical trials: End Stage Disease
Hyperphosphatemia, Kidney Failure
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.
- Trial name
- NCT01191255
- Where
- 56 sites in United States, Israel and 1 more
- Volunteers
- 441 people
- Sponsor
- Keryx Biopharmaceuticals
End Stage Renal Disease
Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels
The purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet HCl into the management of secondary hyperparathyroidism (HPT) to K/DOQI recommended targets in subjects with end stage…
- Trial name
- NCT00113958
- Testing
- Cinacalcet
- Sponsor
- Amgen
Hemophilia A, Hemophilia B
Study of Ataluren (PTC124) in Hemophilia A and B
Hemophilia A (HA) and hemophilia B (HB) are inherited bleeding disorders caused by mutations in the gene for factor VIII (FVIII) and factor IX (FIX), respectively. These proteins are essential for blood clotting.
- Trial name
- NCT00947193
- Testing
- Ataluren
- Where
- 13 sites in United States, Canada and 2 more
- Volunteers
- 13 people
- Sponsor
- PTC Therapeutics
Chronic Renal Insufficiency, End-Stage Renal Disease
A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.
- Trial name
- NCT00097617
- Volunteers
- 395 people
- Sponsor
- Genentech, Inc.
CKD Anemia in Dialysis Participants
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.
- Trial name
- NCT04059913
- Testing
- Roxadustat
- Where
- 25 sites in China
- Volunteers
- 318 people
- Sponsor
- Kyntra Bio
End Stage Kidney Disease
The Vascutek Rapidax™ II Post Market Surveillance Registry
Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
- Trial name
- NCT01977508
- Testing
- ePTFE vascular access grafts
- Where
- 3 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Vascutek Ltd.
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.
End Stage Renal Disease
Acid-Base Composition With Use of hemoDialysates
This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid…
- Trial name
- ABChD (NCT02334267)
- Testing
- Group 1: GranuFlo, Group 2: NaturaLyte
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Fresenius Medical Care North America
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis, End Stage Renal Disease on Dialysis
- Trial name
- NCT06712654
- Testing
- AP306 75 mg BID, AP306 125 mg BID, AP306 150 mg BID
- Where
- 31 sites in United States, China
- Volunteers
- 168 people
- Sponsor
- R1 Therapeutics
End Stage Renal Disease
Confirmatory Study to Assess the V Needle in End-Stage Renal Disease Patients During In-Clinic Hemodialysis
This study is a prospective, multi-center, single-arm study with subjects acting as their own control designed to confirm the safety, performance, and usability of the V Needle, a new safety needle for use during in-clinic…
- Trial name
- Clinic-SAVER (NCT05493423)
- Testing
- V Needle AV Fistula Set
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Hemotek Medical Inc
Duchenne Muscular Dystrophy, Becker Muscular Dystrophy
Phase 2B Extension Study of Ataluren (PTC124) in Duchenne/Becker Muscular Dystrophy (DMD/BMD)
Duchenne/Becker muscular dystrophy (DMD/BMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function.
- Trial name
- NCT00847379
- Testing
- Ataluren
- Where
- 37 sites in United States, Australia and 9 more
- Volunteers
- 173 people
- Sponsor
- PTC Therapeutics
Chronic Kidney Failure, Secondary Hyperparathyroidism
Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism
The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product…
- Trial name
- NCT01081665
- Where
- 19 sites in Greece
- Volunteers
- 237 people
- Sponsor
- Abbott
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.
ESRD (End Stage Renal Disease)
Fluid Status of Dialysis Subjects
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.
- Trial name
- NCT07217041
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HemoCept Inc.
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
End Stage Renal Disease
A Multi-Centered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 (Zuragen) Solution, and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis
The purpose of this study is to determine if AAT-023 (Zuragen) solution is superior to Heparin in preventing Catheter Related Blood Stream Infections for End Stage Renal Disease patients.
- Trial name
- NCT00628680
- Testing
- AAT-023 solution (Zuragen), Heparin
- Where
- 22 sites in United States
- Volunteers
- 415 people
- Sponsor
- Ash Access Technology
Renal Insufficiency
Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects
The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.
- Trial name
- NCT03087942
- Testing
- QAW039, QAW39A, QAW39A2107
- Where
- 2 sites in United States, Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease
Xeltis Hemodialysis Access (aXess) Conduit: aXess-E Study
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to…
- Trial name
- NCT06329310
- Testing
- aXess-E conduit
- Where
- 2 sites in Portugal, Serbia
- Volunteers
- 20 people
- Sponsor
- Xeltis
Chronic Kidney Diseases, Pruritus
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced 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 oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in…
- Trial name
- NCT05356403
- Testing
- Difelikefalin 1 mg Oral Tablet
- Where
- 75 sites in United States, Argentina and 11 more
- Volunteers
- 105 people
- Sponsor
- Cara Therapeutics, Inc.
End Stage Liver DIsease, Liver Failure
VitaSmart HOPE System: Bridge to HOPE Registry
This is a post-market, multicenter, single-arm, observational registry evaluating real-world use of the VitaSmart HOPE System under standard of care conditions.
- Trial name
- NCT07578441
- Testing
- hypothermic oxygenated perfusion therapy of a donor liver under standard of care conditions
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Bridge to Life Ltd.