Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693381

Acronym

DISTAMP

Enrollment

152

Registered

2008-06-09

Start date

2003-02-28

Completion date

2004-08-31

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Transplantation, Graft Rejection, Renal Transplantation

Brief summary

Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.

Interventions

DRUGTacrolimus

oral

DRUGMycophenolate Mofetil

oral

DRUGmethylprednisolone and prednisone

IV and oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation * Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type

Exclusion criteria

* Patient has an immunological high risk, defined as having a most recently measured PRA grade of \>= 50% within the previous six months * Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation * Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) * Patient or donor is known to be HIV positive * Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully * Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer * Patient is receiving a graft from a non-heart-beating donor * Cold ischemia time of the donor kidney \>= 40 hours

Design outcomes

Primary

Measure	Time frame
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation	6 months

Secondary

Measure	Time frame
Incidence and seriousness of adverse events	6 months

Countries

Czechia, Hungary, Poland, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026