MedTrace Logo

Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)

NCT04114188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-01-29

No results posted yet for this study

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.

Conditions

  • Renal Transplant Rejection

Interventions

DRUG

Antithymocyte Immunoglobulin (Rabbit)

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.

Sponsors & Collaborators

  • Institut Klinické a Experimentální Medicíny

    collaborator UNKNOWN

  • Prof. Dr. Petra Reinke

    lead OTHER

Principal Investigators

  • Reinke Reinke, PhD, MD · Charité-University Medicine (Berlin, Germany)

  • Ondrej Viklicky, PhD, MD · Institute for Clinical and Experimental Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04114188 on ClinicalTrials.gov