NCT00693381

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2003

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

1.5 years

First QC Date

June 3, 2008

Last Update Submit

September 17, 2014

Conditions

Kidney Transplantation

Keywords

TransplantationGraft RejectionRenal Transplantation

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • Incidence and seriousness of adverse events

    6 months

Study Arms (2)

1

EXPERIMENTAL

Tacrolimus/MMF/steroids throughout the study

Drug: TacrolimusDrug: Mycophenolate MofetilDrug: methylprednisolone and prednisone

2

EXPERIMENTAL

Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3

Drug: TacrolimusDrug: Mycophenolate MofetilDrug: methylprednisolone and prednisone

Interventions

TacrolimusDRUG

oral

Also known as: Prograf, FK506
12
Mycophenolate MofetilDRUG

oral

Also known as: CellCept
12
methylprednisolone and prednisoneDRUG

IV and oral

Also known as: Steroids
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Ostrava, Czechia

Location

Unknown Facility

Debrecen, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lublin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Zabrze, Poland

Location

Unknown Facility

Banska, Slovakia

Location

Related Publications (1)

  • Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x.

    PMID: 17291216BACKGROUND

MeSH Terms

Interventions

TacrolimusMycophenolic AcidMethylprednisolonePrednisoneSteroids

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsPrednisolonePregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Study Officials

  • Central Contact

    Astellas Pharma Europe B.V.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 9, 2008

Study Start

February 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

HU(2)PL(7)CZ(4)SL(1)