Clinical trials: Kidney Transplant Rejection
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.
Kidney Transplant Failure and Rejection
Assessment of QSant™ for Underlying Allograft Rejection
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test.
- Trial name
- AQUA (NCT05282966)
- Testing
- QSant-TM Urine Test
- Volunteers
- 4,000 people
- Sponsor
- NephroSant
Liver Dysfunction, Rejection, Transplant
Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection
This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection.
- Conditions
- Liver Dysfunction, Rejection, Transplant, Transplantation, Liver
- Trial name
- NCT00117689
- Testing
- Thymoglobulin, Corticosteroid, Tacrolimus
- Where
- 16 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Genzyme, a Sanofi Company
Kidney Transplant Rejection
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT06126380
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 132 people
- Sponsor
- Eledon Pharmaceuticals
Prevention of Rejection in Kidney Transplant
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
- Trial name
- NCT05027906
- Testing
- AT-1501
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 48 people
- Sponsor
- Eledon Pharmaceuticals
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
Kidney Transplantation
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.
- Trial name
- NCT00133172
- Testing
- Tacrolimus, mycophenolate mofetil, Prednisone
- Where
- 14 sites in Canada
- Volunteers
- 85 people
- Sponsor
- Astellas Pharma Inc
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
Kidney Transplantation
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.
- Trial name
- NCT00099736
- Testing
- FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids, FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids, MMF 2 g + full-dose Neoral (FDN) + corticosteroids
- Where
- 42 sites in United States
- Volunteers
- 696 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients.
- Trial name
- NCT04711850
- Testing
- Imlifidase
- Where
- 7 sites in Austria, France and 1 more
- Volunteers
- 18 people
- Sponsor
- Hansa Biopharma AB
Transplant Rejection, Transplant Kidney
Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients
It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for…
- Trial name
- PLAKID-TRANSP (NCT06910527)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Poulet Geoffroy
Antibody-mediated Rejection, Microvascular Inflammation
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI).
- Trial name
- NCT07444489
- Testing
- Felzartamab
- Where
- 14 sites in United States
- Volunteers
- 201 people
- Sponsor
- Biogen
Kidney Transplantation, Renal Transplantation
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in…
- Trial name
- ATHENA (NCT01843348)
- Testing
- Everolimus, Tacrolimus, Cyclosporin A
- Where
- 27 sites in France, Germany
- Volunteers
- 612 people
- Sponsor
- Novartis Pharmaceuticals
Antibody-Mediated Rejection (AMR)
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.
- Trial name
- NCT07613359
- Testing
- Mezagitamab
- Where
- 35 sites in United States, China and 3 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics 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
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants
The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or…
- Trial name
- NCT03605654
- Testing
- MDR-102, Immunosuppressive Agents
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection
TruGraf and TRAC In Pediatrics Study
This is a pilot 3 center prospective study of pediatric renal kidney recipients undergoing protocol biopsies examining the performance of the TruGraf gene expression test in children and adolescents.
- Trial name
- TTIPS (NCT05335538)
- Testing
- Patients monitored with TruGraf and TRAC testing
- Where
- 3 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Transplant Genomics, Inc.
Liver Transplant
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Assuming greater efficacy in the prevention of acute rejection in the EVR arm with minimisation of TAC levels, the hypothesis of the present trial was that the introduction of EVR in combination with the minimisation of TAC…
- Trial name
- REDUCE (NCT02040584)
- Testing
- Minimisation of TAC, TAC + MMF + corticosteroids
- Where
- 20 sites in Spain
- Volunteers
- 217 people
- Sponsor
- Novartis Pharmaceuticals
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