Clinical trials: Subclinical Rejection
Kidney Transplant Rejection
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)
Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs)…
- Trial name
- BELA-M-R (NCT06291103)
- Testing
- Conversion to Belatacep, Standard of care treatment (SOC regimen) with Tacrolimus
- Where
- France
- Volunteers
- 290 people
- Sponsor
- University Hospital, Rouen
Kidney Transplant Rejection
ddcfDNA in Kidney Transplant Recipients
The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation.
- Trial name
- NCT06013358
- Testing
- AlloSeq cfDNA
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Seoul National University Hospital
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.
Renal Transplant Rejection
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept®…
- Trial name
- IBERICA (NCT01324934)
- Testing
- ATG-Fresenius S
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 40 people
- Sponsor
- Neovii Biotech
Kidney Transplantation
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 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
CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
This is a prospective, multi-site, observational study with a matched control group. The primary objective is to evaluate change in renal function over time in recipients of kidney transplants who are undergoing OmniGrafTM…
- Trial name
- CLARITY (NCT05482100)
- Testing
- Patients monitored with OmniGraf testing
- Volunteers
- 500 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplantation
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with…
- Trial name
- NCT02005562
- Testing
- mycophenolate mofetil, anti-IL-2R, methylprednisolone
- Where
- 24 sites in France
- Volunteers
- 252 people
- Sponsor
- Hoffmann-La Roche
Antibody-mediated Rejection, Lung Transplant Rejection
A Prospective Randomized Trial of ECP in Subclinical AMR
The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are: 1.
- Trial name
- EUROEXPORT-DSA (NCT06112951)
- Testing
- Extracorporeal Photopheresis
- Where
- 7 sites in Austria, Belgium and 5 more
- Volunteers
- 80 people
- Sponsor
- Medical University of Vienna
Kidney Transplant Rejection
Pilot Study of Treatment for Subclinical AMR (Antibody-mediated Rejection) in Kidney Transplant Recipients
This is a pilot study to determine if extended release Envarsus at an optimal level is just as effective as more invasive standard therapies for subclinical (mild) AMR (antibody mediated rejection) in kidney transplant patients.
- Trial name
- NCT03380936
- Testing
- Tacrolimus Extended Release Oral Tablet [Envarsus], Plasma Exchange and IVIG (Intravenous Immunoglobulin )
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Colorado, Denver
Liver Transplant Rejection
TRU-IMMUNO: Optimizing Liver Immunosuppression
This is a prospective, multi-center, randomized study. The primary objective is to evaluate the feasibility and utility of TruGraf/TRAC Liver testing used in addition to standard of care measures of liver dysfunction to guide…
- Trial name
- NCT05335551
- Testing
- Patients monitored with TruGraf and TRAC Liver testing
- Volunteers
- 130 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplant Rejection, Kidney Transplant; Complications
Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients
The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called "subclinical" rejection, ie without any clinical or biological…
- Trial name
- NCT04702022
- Testing
- 18FDG PET / CT
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- University of Liege
Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation
Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection.
- Trial name
- TAMARCIN (NCT02113891)
- Testing
- Eculizumab
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Renal Failure
The Effect of Steroid Pulse Therapy for the Reduction of Acute Rejection Episode in Subclinical Borderline Changes
Several studies have shown that about 30% of transplanted kidneys with stable function present with tubule-interstitial mononuclear cell infiltration in protocol biopsies and therefore meet criteria for acute rejection.
- Trial name
- NCT02664493
- Testing
- Methylprednisolone
- Where
- South Korea
- Volunteers
- 154 people
- Sponsor
- Samsung Medical Center
Chronic Renal Failure
The Impact of Early Protocol Biopsy in Kidney Transplant
The purpose of this study is evaluating the impact of steroid pulse therapy (SPT) on SCR revealed on PB in KT recipients maintained on TAC/MMF and corticosteroid.
- Trial name
- NCT02733510
- Testing
- methylprednisolone
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
Kidney Transplant Rejection
PROACT Pilot Trial
Kidney transplantation is considered the best option to treat end-stage kidney disease, but the recipient's immune system may respond with rejection to the transplanted organ, leading to permanent kidney damage and failure.
- Trial name
- NCT06564649
- Testing
- CXCL10 Monitoring at clinical frequency
- Where
- 3 sites in Canada
- Volunteers
- 60 people
- Sponsor
- University of British Columbia
Kidney Transplant Failure and Rejection
Treatment of Early Borderline Lesions in Low Immunological Risk Kidney Transplant Patients (TRAINING)
Background: Subclinical inflammation, including borderline lesions (BL), is very common (30-40%) after kidney transplantation (KT), even in low immunological risk patients, and can lead to interstitial fibrosis/tubular atrophy…
- Trial name
- NCT04936282
- Testing
- Grafalon, Normal Treatment
- Where
- 4 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Fundación Canaria Instituto de Investigación Sanitaria de Canarias
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
End Stage Renal Disease
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus.
- Trial name
- NCT03321656
- Testing
- Tacrolimus, Envarsus XR
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Roberto Gedaly
Kidney Transplantation
Effect of Privigen Against Graft Loss
The principal objective of this pilot study is to determine whether the progression of chronic antibody-mediated rejection (ABMR) could be minimized by the post-transplant administration of high dose of Intravenous…
- Trial name
- InAuGuRAL (NCT02374736)
- Testing
- Privigen (Human normal immunoglobulin G (IgG > 98 % purity))
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris