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

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:

MedlinePlus related topics: Kidney Transplantation Steroids

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

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

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 BV

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 May 22, 2013

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