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Completed

NCT Number: NCT00650468

A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

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Key information

Conditions

Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Little Rock, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Patient is between post kidney transplant day 3-7 and no requirement for dialysis

Exclusion:

  • Patient is receiving kidney from HLA identical,living donor
  • Patient is a multi-organ transplant recipient
  • Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control

Treatment and study plan

Tacrolimus

Drug

Oral

Other names: Prograf, FK506

CellCept

Drug

IV or Oral

Other names: MMF, Mycophenolate mofetil

steroids (methylprednisone or prednisone)

Drug

IV or Oral

Other names: methylprednisone, prednisone

Primary outcomes

  1. Assessment of death, graft loss, or severe acute rejection

    Time frame: 6 months, 12 months, yearly up to 5 years

Secondary outcomes

  1. Comparison of patient and graf survival

    Time frame: 6 months, 12 months, yearly up to 5 years

  2. Incidence and severity of acute rejection

    Time frame: 6 months, 12 months, yearly up to 5 years

  3. Need for antilymphocyte treatment

    Time frame: 6 months, 12 months, yearly up to 5 years

  4. Graft function

    Time frame: 6 month, 12 months, yearly up to 5 years

  5. Framingham Coronary Heart Disease Risk Factors

    Time frame: 6 months, 12 months, yearly up to 5 years

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Apr 1, 2008
Registry last updated
Nov 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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