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OpenTrials
Completed

NCT Number: NCT00374647

Study to Evaluate Safety and Efficacy of Early Calcineurin Inhibitor Withdrawal in Primary Renal Allografts

Evaluate the safety and efficacy of early corticosteroid withdrawal and simultaneous calcineurin inhibitor withdrawal in recipients of primary renal allografts maintained long-term on MMF and sirolimus.

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Key information

Conditions

Primary Renal Allograft

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Christ Hospital, Cincinnati, Ohio, 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 criteria

  • Male and female patients between 18 and 75 years of age.
  • Patients who are 90 to 240 days after having received a primary living or cadaver renal allograft.
  • Patients maintained on a regimen of cyclosporine or tacrolimus and MMF since transplantation.
  • Capable of providing written informed consent.
  • No known contraindications to treatment with sirolimus.

Exclusion criteria

  • Pregnant or lactating.
  • Acute rejection within 90 days prior to study randomization.
  • More than one biopsy proven acute rejection episode prior to study randomization.
  • Previously received or are receiving an organ transplant other than kidney.
  • Receiving sirolimus prior to entry.
  • Severe diarrhea or other gastrointestinal disorders that may interfere with their ability to absorb oral medication.
  • Evidence of active systemic infection requiring antibiotics, or HIV, HCV, HBV infection.
  • History of malignancy in the past 5 years.
  • Require dialysis at the time of study entry.

Treatment and study plan

Mycophenolate mofetil

Drug

sirolimus

Drug

Primary outcomes

  1. Composite endpoint of either acute rejection, biopsy proven calcineurin inhibitor toxicity, or failure of the estimated BSA indexed GFR by MDRD method to improve by 20% from time randomization to 12 months.

Secondary outcomes

  1. Renal allograft function at 6 and 12 months.

  2. Incidence of biopsy proven acute rejection at 6 and 12 months.

  3. Time to first rejection.

  4. Total number of rejection episodes per patient.

  5. Graft loss and patient death.

  6. Incidence of treatment failure.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

Open Label Randomized Single Study to Evaluate the Safety & Efficacy of Early CNI Withdrawal in Recipients of Primary Renal Allografts Maintained Long-Term on Mycophenolate Mofetil; MMF (CellCept) and Sirolimus (Rapamune)

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 11, 2006
Registry last updated
Jul 15, 2021

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.