Clinical Trials Logo
  1. Home
  2. Renal Transplant Rejection
  3. NCT04114188

Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI) — RIMINI  

Renal Transplant Rejection Clinical Trial

Official title:
Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)

Clinical Trial Summary

International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.

Clinical Trial Description

A total of 75 patients will receive the proposed induction regimen, with expected 68 completers accounting for drop-outs and non-compliances with the protocol. If up to 27 out of the 68 completers experience efficacy failure, a progression into a larger trial will be considered justifiable. If the number of patients experiencing efficacy failure is between 28 and 34 out of 68, the merits of a larger non-inferiority design will be considered depending on the risk/benefit assessment. If more than 34 out of the 68 completers experience efficacy failure, a progression into a larger trial would be considered unjustifiable. 1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy. All patients will be followed up for one year. At the POD 0 the first rATG dose (1.5mg/kg) will be given according to the local practice and Methyprednisolon 500mg will be given before reperfusion. At the POD 1 patients will receive methylprednisolon 500mg i.v. followed by second rATG dose (1.5mg/kg). Infliximab 5mg/kg b.w. will be given in slow infusion on POD2. Tacrolimus will be given the first dose before surgery at dose 0.1 mg/kg and next from POD1 at 0.2mg/kg/day and doses adjusted according to blood trough levels (10-15 ng/mL, POD1-POD13, 5-8ng/mL POD 14-90, 4-6ng/mL POD >90. Prednison (or appropriate dose of methylprednisolone) will be initiated POD 2 at a dose of 20mg/day and slowly tapered down to 5 mg at the POD 7 (POD2: 20mg, POD3: 15mg, POD4-5: 10mg, POD6-7: 7,5mg, > POD7: 5mg). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04114188
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase Phase 2
Start date December 15, 2016
Completion date December 31, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03140514 - Urine CXCL10 Chemokine Monitoring Post-renal Transplant N/A
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Active, not recruiting NCT02409940 - To Elucidate the Effect of Mesenchymal Stem Cells on the T Cell Repertoire of the Kidney Transplant Patients Phase 1
Completed NCT02377193 - Simulect Versus ATG in Sensitized Renal Transplant Patient Phase 4
Completed NCT00771745 - Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients Phase 4
Not yet recruiting NCT05385432 - Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies Phase 3
Completed NCT01953120 - Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309) Phase 4
Terminated NCT01324934 - Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids Phase 3
Terminated NCT00983645 - A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity Phase 4
Active, not recruiting NCT04530630 - Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant Phase 4
Recruiting NCT03707262 - Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor Phase 1/Phase 2
Completed NCT02006108 - Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance N/A
Recruiting NCT03991780 - Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection Phase 1/Phase 2
Completed NCT02733029 - Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection Phase 2
Active, not recruiting NCT02057965 - Mesenchymal Stromal Cell Therapy in Renal Recipients Phase 2
Completed NCT00658073 - Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts N/A
Terminated NCT03646344 - Heme Arginate in Transplantation Study Phase 3
Completed NCT02866682 - Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients Phase 4
Not yet recruiting NCT06438107 - Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes
Completed NCT02500251 - Belimumab Impacting Transplant Eligibility Phase 1/Phase 2