Clinical trials: Kidney Transplant Immunosuppression, open to volunteers
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
End-stage Renal Disease (ESRD), Kidney Transplantation
Microbiota Changes Related to Outcomes in Kidney Transplantation
Chronic kidney disease affects approximately 10% of the world population. End-stage renal disease (ESRD) is associated with immune dysregulation, chronic inflammation, and alteration of the gut and urinary microbiota.
- Trial name
- MICRO-KT (NCT07893691)
- Testing
- Fecal samples, Urinary sample, Blood samples
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Diabete Type 1, Chronic Kidney Disease
Breakthrough - T1DM and Chronic Kidney Disease
Single arm- subject treated with Tegoprubart and everolimus. The purpose of this research is to gather information on the safety and effectiveness of investigational regimen containing 2 experimental components: An…
- Trial name
- NCT07592000
- Testing
- Tegoprubart, Islet Cell Transplant
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- University of Chicago
Kidney Transplant, Immunosuppresion
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
- Trial name
- IMPAKT (NCT07718633)
- Testing
- Prospera Immunosuppression Optimization
- Volunteers
- 750 people
- Sponsor
- Natera, Inc.
Kidney Transplant Immunosuppression
Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial…
- Trial name
- NCT06336863
- Testing
- Allosure and TruGraf, Immunosuppression Taper
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Texas Southwestern Medical Center
Renal-urinary Impairment, Graft Rejection
Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients
BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow…
- Conditions
- Renal-urinary Impairment, Graft Rejection, Infection Episodes
- Trial name
- BKV-Pneumo (NCT04164576)
- Testing
- Transplant patients
- Where
- France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Strasbourg, France
Kidney Transplantation
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
In this clinical trial the investigational medicinal product MIC is to be examined for its efficacy and safety in patients with living kidney transplantation.
- Trial name
- NCT05365672
- Testing
- MIC, Standard of Care
- Where
- 8 sites in Germany
- Volunteers
- 126 people
- Sponsor
- TolerogenixX GmbH
Infection, Cancer
TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation
Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient…
- Conditions
- Infection, Cancer, Rejection, Kidney Transplantation
- Trial name
- TAOIST (NCT06829719)
- Testing
- TTV DNAemia, EQ-5D-5L questionnaire, Biological tests
- Where
- 4 sites in France
- Volunteers
- 600 people
- Sponsor
- Hospices Civils de Lyon
Renal Transplantation
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction
Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection.
- Trial name
- NCT05086003
- Testing
- Combined kidney and bone marrow transplantation
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Rabin Medical Center
Renal Failure , Chronic, Graft Failure
Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure
The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression…
- Conditions
- Renal Failure , Chronic, Graft Failure, Graft Rejection, Allograft
- Trial name
- NCT06676696
- Testing
- Continue low dose calcineurin inhibitor (CNI), Calcineurin inhibitor withdrawal at 6 months
- Where
- Spain
- Volunteers
- 202 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Kidney Transplantation, Mycophenolate Mofetil
Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.
The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant.
- Trial name
- RIOT (NCT06568549)
- Testing
- Mycophenolate Mofetil (MMF) Maintenance Group, Mycophenolate Mofetil (MMF) Withdrawal Group
- Where
- 3 sites in United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Kidney Transplant Rejection
AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function
The objective of the proposed study it to perform a pilot clinical trial both to establish feasibility of applying a computational, augmented intelligence based approach, Phenotypic Precision Medicine (PPM), to optimizing…
- Trial name
- AIIM (NCT05432765)
- Testing
- Phenotypic Personalized Medicine Dosing, Standard of Care Dosing
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Florida
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.
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 24 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
Kidney Transplant, Kidney Transplant Failure
Prevent Allosensitization in Patients Who Have Failed a First Renal Transplant (PART)
Kidney transplant is often the best treatment for people with kidney failure, but transplanted kidneys don't always last a lifetime.
- Conditions
- Kidney Transplant, Kidney Transplant Failure, Immunosuppresion
- Trial name
- NCT06802822
- Testing
- Prevention of Allosensitization
- Where
- Canada
- Volunteers
- 96 people
- Sponsor
- University of British Columbia
Diabetes
Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye
The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing…
- Trial name
- NCT02846571
- Testing
- Human Pancreatic Islet Transplantation
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Midhat H. Abdulreda
Graft Failure, Death
European Transplant Registry of Senior Renal Transplant Recipients on Advagraf
SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate…
- Conditions
- Graft Failure, Death, Acute Rejection of Renal Transplant, Infections
- Trial name
- SENIOR (NCT02558452)
- Testing
- Tacrolimus once daily (Advagraf)
- Volunteers
- 1,000 people
- Sponsor
- Klemens Budde
Kidney Transplant Recipient
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Most kidney transplant recipients take a combination of anti-rejection medicines for the rest of their life. One of these is called mycophenolate mofetil (MMF), also known by the brand name CellCept.
- Trial name
- OPTIMA-KT (NCT07806136)
- Testing
- Tacrolimus (Kidney transplant maintenance immunosuppression), Mycophenoate Mofetil, Prednisone (SOC arm)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Virginia Commonwealth University
Kidney Transplantation, Antibody-mediated Rejection
CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients
This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38…
- Trial name
- CAZA (NCT07718308)
- Testing
- CD38, Azathioprine (AZA), Standard Triple Immunosuppression Maintenance
- Volunteers
- 20 people
- Sponsor
- wujianyong
Pediatric Kidney Disease, Transplant;Failure,Kidney
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Currently, the monitoring of children receiving a kidney transplantation includes surveillance biopsies to detect subclinical rejection and signs of toxicity of immunosuppressive drugs (tacrolimus).
- Trial name
- MONITOR (NCT06761482)
- Testing
- monitoring by dd-cfDNA, monitoring by T-Vis, monitoring by dd-cfDNA+ T-Vis
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris