Clinical trials: Transplant; Failure, Kidney
Kidney Transplantation
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
- Trial name
- ADHERE (NCT01363752)
- Testing
- Advagraf, Mycophenolate Mofetil, Sirolimus
- Where
- 58 sites in Australia, Austria and 15 more
- Volunteers
- 853 people
- Sponsor
- Astellas Pharma Inc
End Stage Renal Disease
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
- Trial name
- NCT07696962
- Testing
- ChoironeX GalKO Porcine Thymokidney
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Xeno Holdings (US), LLC dba ChoironeX
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 Transplant Rejection
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
- Trial name
- LEGACY (NCT07835581)
- Testing
- Tegoprubart, Tacrolimus
- Volunteers
- 620 people
- Sponsor
- Eledon Pharmaceuticals
End Stage Renal Disease, Hemodialysis Access Failure
PReSeRVE-HD: Observational Study of the Merit HeRO® Graft and Super HeRO® in Patients on Hemodialysis
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices.
- Trial name
- PReSeRVE-HD (NCT06422871)
- Testing
- HeRO® Graft System or Super HeRO® System
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- Merit Medical Systems, Inc.
Kidney Transplantation in Highly Sensitized Patients
Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts
An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior…
- Trial name
- PAES (NCT05369975)
- Testing
- Imlifidase, Normal Transplantation Routine
- Where
- 22 sites in Austria, Belgium and 9 more
- Volunteers
- 113 people
- Sponsor
- Hansa Biopharma AB
Renal Failure, Tremors
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro.
- Trial name
- STRATO (NCT01438710)
- Testing
- Prograf, LCP-Tacro
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Veloxis Pharmaceuticals
Kidney Failure, Graft vs Host Disease
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune…
- Trial name
- NCT00195468
- Testing
- CYCLOSPORINE
- Where
- 13 sites in Brazil, Mexico
- Volunteers
- 280 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Chronic Renal Failure
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard…
- Trial name
- NCT00965094
- Testing
- Everolimus, Tacrolimus (FK506), Basiliximab
- Where
- 3 sites in Israel
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Renal Disease
Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus [Life-Cycle Pharma Tacrolimus] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and…
- Trial name
- NOVOSTART (NCT06960824)
- Testing
- Life-Cycle Pharma Tacrolimus, Kidney transplantation
- Where
- France
- Volunteers
- 165 people
- Sponsor
- Chiesi SAS
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.
Renal Failure
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly…
- Trial name
- LCPTacro3002 (NCT01187953)
- Testing
- Prograf (tacrolimus), LCP-Tacro
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 543 people
- Sponsor
- Veloxis Pharmaceuticals
End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD)
Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy
- Trial name
- TRANSFORM (NCT01950819)
- Testing
- Induction therapy, Corticosteroids, EVR+rCNI
- Where
- 184 sites in United States, Argentina and 40 more
- Volunteers
- 2,037 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease (ESRD)
HeRO Graft Compared to Permanent Catheters for End Stage Renal Disease (ESRD) Patients Receiving Hemodialysis
The main objective of this research study was to compare the following outcomes between patients with a Hemodialysis Reliable Outflow (HeRO) Graft and patients with a cuffed catheter for dialysis access over one year: quality of…
- Trial name
- NCT01343251
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Merit Medical Systems, 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
Transplant;Failure,Kidney
Real-time Monitoring of Kidney Grafts on Hypothermic Machine Perfusion
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation.
- Trial name
- REMO-HYMAP (NCT04619732)
- Testing
- Monitoring biochemical concentrations during cold machine perfusion
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Accunea Ltd.
Coronary Artery Bypass Surgery, Coronary Heart Disease
Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA
The purpose of this study is to assess the effects of nesiritide compared to placebo when given with standard of care therapies, on kidney function, heart function and the need of other treatments in heart failure patients…
- Conditions
- Coronary Artery Bypass Surgery, Coronary Heart Disease, Coronary Artery Bypass Grafting, Cardiopulmonary Bypass
- Trial name
- NCT00653042
- Testing
- Nesiritide
- Volunteers
- 305 people
- Sponsor
- Scios, Inc.
Graft Rejection, Kidney Failure
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.
- Conditions
- Graft Rejection, Kidney Failure, Kidney Transplantation
- Trial name
- NCT00273871
- Testing
- Cyclosporin or tacrolimus
- Volunteers
- 190 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplant Rejection
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03606746
- Testing
- MDR-103
- Sponsor
- Medeor Therapeutics, Inc.
Renal Failure
Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf…
- Trial name
- NCT00496483
- Testing
- LCP Tacro (tacrolimus), Prograf
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Veloxis Pharmaceuticals