Clinical trials: Transplant; Complication, Failure
Kidney Failure, Chronic
A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation
This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease (ESRD).
- Trial name
- NCT02586051
- Testing
- Obinutuzumab, Intravenous Immunoglobulin
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
ESRD (End-Stage Renal Disease), Kidney Transplantation
Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1)…
- Conditions
- ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
- Trial name
- EXTEND (NCT07224763)
- Testing
- GGTA1 KO Thymokidney
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United Therapeutics
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
The objective of this trial is to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in single lung transplant recipients with…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-1 (NCT03657342)
- Testing
- Liposomal Cyclosporine A, standard of care
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 62 people
- Sponsor
- Zambon SpA
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Congestive Heart Failure, Cardiac Transplantation
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide).
- Conditions
- Congestive Heart Failure, Cardiac Transplantation, Renal Insufficiency, Renal Failure
- Trial name
- NCT00338455
- Testing
- Natrecor (nesiritide)+Standard Care+dobutamine or milrinone
- Where
- 14 sites in United States
- Volunteers
- 16 people
- Sponsor
- Scios, Inc.
Fanconi Anemia Complementation Group A, Fanconi Anemia
Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy
This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial.
- Trial name
- NCT04437771
- Testing
- Safety and efficacy assessments
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Hypospadias
Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure
The purpose of this trial is to assess the safety and efficacy of Holour in patients suffering from hypospadias treatment failure.
- Trial name
- HOLOUR (NCT05093166)
- Testing
- "Ex vivo" expanded autologous human oral epithelium containing stem cells
- Where
- Italy
- Volunteers
- 1 people
- Sponsor
- Holostem s.r.l.
Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis.
- Trial name
- AVG22-09 (NCT05846581)
- Testing
- GORE® ACUSEAL Vascular Graft
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 72 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared With Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in de Novo Kidney Transplant Patients
The purpose of the study is to compare tacrolimus dosing of the new Envarsus®-based immunosuppressive regimen with current clinical practice (Prograf or Advagraf) over 6 months following de novo renal transplantation in a…
- Trial name
- STEADY (NCT02432833)
- Testing
- ENVARSUS®, PROGRAF®, ADVAGRAF®
- Where
- Italy
- Volunteers
- 428 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
End Stage Renal Disease
Xeltis Hemodialysis Access Graft (aXess) US Study
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and…
- Trial name
- NCT06494631
- Testing
- Xeltis Hemodialysis Access (aXess) graft
- Where
- 7 sites in United States
- Volunteers
- 140 people
- Sponsor
- Xeltis
Kidney Failure
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
- Trial name
- NCT00497926
- Testing
- Enriched Hematopoietic Stem Cell Infusion
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Talaris Therapeutics Inc.
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
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft in AV Graft Patients (AVeVA)
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeVA (NCT02790606)
- Testing
- Covera(TM) Vascular Covered Stent
- Where
- 16 sites in United States
- Volunteers
- 110 people
- Sponsor
- C. R. Bard
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
Graft Rejection, Kidney Failure
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction…
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00261820
- Testing
- tacrolimus, mycophenolate mofetil, methylprednisolone
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
End Stage Renal Disease (ESRD)
Multi-Site STARgraft (10401) Trial
This is a multi-site, single-blind with parallel group, randomized controlled trial of Healionics STARgraft (10401) vascular graft for hemodialysis access compared with a market-leading commercially available ePTFE vascular graft…
- Trial name
- NCT07557862
- Testing
- STARgraft (10401), Gore Propaten
- Where
- 7 sites in Brazil, Colombia
- Volunteers
- 111 people
- Sponsor
- Healionics Corporation