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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00693381
First received: June 3, 2008
Last updated: December 4, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Drug: methylprednisolone and prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and seriousness of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: February 2003
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tacrolimus/MMF/steroids throughout the study
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Name: CellCept
Drug: methylprednisolone and prednisone
IV and oral
Other Name: Steroids
Experimental: 2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Name: CellCept
Drug: methylprednisolone and prednisone
IV and oral
Other Name: Steroids

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693381

Locations
Czech Republic
Brno, Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Ostrava, Czech Republic
Hungary
Debrecen, Hungary
Pecs, Hungary
Poland
Bialystok, Poland
Gdansk, Poland
Krakow, Poland
Lublin, Poland
Warsaw, Poland
Wroclaw, Poland
Zabrze, Poland
Slovakia
Banska, Slovakia
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00693381     History of Changes
Other Study ID Numbers: FG-506-02-CEE-01
Study First Received: June 3, 2008
Last Updated: December 4, 2008
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Slovakia: State Institute for Drug Control

Keywords provided by Astellas Pharma Inc:
Transplantation
Graft Rejection
Renal Transplantation

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 29, 2014