Clinical trials: Transplant; Failure, Kidney
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
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
Chronic Kidney Disease
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor specific antibodies to reduce the antibody load and thus enable kidney transplantation.
- Trial name
- NCT02224820
- Testing
- IdeS
- Where
- Sweden
- Volunteers
- 8 people
- Sponsor
- Hansa Biopharma AB
Chronic Kidney Insufficiency
Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
- Trial name
- NCT01353417
- Testing
- In this observational study no study specific intervention is planned
- Where
- Austria
- Volunteers
- 102 people
- Sponsor
- Sandoz
Kidney Transplant Failure and Rejection
Prospective Assessment of Rejection in Kidney Transplant (PARK)
The PARK study is a multi-center observational study to assess the performance of the QSant test with kidney biopsy. QSant is a test based on 6 urinary biomarkers that is used for the evaluation and management of acute rejection…
- Trial name
- PARK (NCT05715853)
- Testing
- QSant
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- NephroSant
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.
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 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.
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd
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, End Stage Renal Failure on Dialysis
First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft
A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.
- Trial name
- aXess-FIH (NCT04898153)
- Testing
- aXess
- Where
- 6 sites in Belgium, Italy and 2 more
- Volunteers
- 20 people
- Sponsor
- Xeltis
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
Renal Failure
Expanded Access Study for Renal Transplant Patients With Envarsus XR ™
Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR (Tacrolimus).
- Trial name
- NCT02411604
- Testing
- Tacrolimus
- Sponsor
- Veloxis Pharmaceuticals
Acute Kidney Injury (AKI)
Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury (AKI) Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery
The purpose of this study was to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for AKI following CABG and/or valve surgery.
- Trial name
- NCT03941483
- Testing
- ASP1128
- Where
- 27 sites in United States
- Volunteers
- 351 people
- Sponsor
- Astellas Pharma Inc
End Stage Renal Disease
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.
- Trial name
- NCT04905511
- Testing
- natural human collagen arteriovenous graft for hemodialysis access
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Vascudyne, Inc.
Transplant;Failure,Kidney
Utility of a Novel Dd-cfDNA Test to Detect Injury in Renal Post-Transplant Patients
Detecting allograft injury and rejection is critical to preventing graft loss. The current standard of care (SoC) relies on serum creatinine (SC) and biopsy to monitor for and identify kidney injury earlier.
- Trial name
- QIDNEY (NCT03765203)
- Testing
- Natera KidneyScan, Clinical Performance and Value Vignettes
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Atherosclerosis, Kidney Failure
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of…
- Trial name
- NCT00311311
- Testing
- tacrolimus, mycophenolate mofetil, prednisone
- Where
- 8 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Pfizer
Kidney Failure, Graft vs Host Disease
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
- Trial name
- NCT00195481
- Testing
- Rapamune
- Where
- 5 sites in India
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplant Failure and Rejection
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome…
- Trial name
- NCT03611621
- Testing
- Imlifidase
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 31 people
- Sponsor
- Hansa Biopharma AB
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation