Tacrolimus monotherapy for low risk kidney transplant recipients.

Phase 1

• Conditions: kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-001372-66-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-08
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and:
-Historical PRA <5 and
-HLA MM <4.
Re-transplantation are allowed when meeting the before mentioned criteria.
Patients have to give written informed consent to participate in the study.
Before randomization at 6 months, renal function should be stable with eGFR (CKD-EPI formula) >30 in mL/min with proteinuria =0.5 gram per 10 mmol creatinin in spot urine.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-HLA identical living-related transplant recipients.
-Patients with an indication to continue MMF or other immunosuppressive drugs, e.g. vasculitis, SLE etc. (according to judgement of treating physician).
-Recipient of an ABO-incompatible allograft or with a positive crossmatch (complement-dependent cytotoxicity or flow cytometry).
-Biopsy proven rejection three months and later after transplantation.
-Recipient of multiple organ transplants.
-Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating or who are unwilling to use effective means of contraception.
-T-cell depleting therapy (anti-thymocyte globulin and alemtuzumab) after transplantation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified