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Completed

NCT Number: NCT00087581

Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.

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Key information

Conditions

Kidney Transplantation

Age range

13 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, 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

  • Males or females 13-75 years of age
  • Single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
  • Receiving first or second kidney transplant

Exclusion criteria

  • Immunosuppressive therapy (except for 48 hours prior to transplantation and corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
  • History of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)

Treatment and study plan

Mycophenolate mofetil

Drug

Depending on body surface area and age, MMF may be given in capsule, tablet, oral suspension, or IV form. The initial dose will be at least 1 gram BID in adults and 600 mg/m^2 in pediatrics. In Groups A and B, subsequent doses will be adjusted to maintain blood MPA levels ≥1.3 μg/mL with cyclosporine or ≥1.9 μg/mL with tacrolimus. In Group C, subsequent doses are not to be adjusted, except in the case of unacceptable toxicity.

Other names: CellCept

cyclosporine

Drug

Cyclosporine will be given as 100-mg soft gelatin capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Cyclosporine target concentrations are as follows: Days 1-30, 250-325 ng/mL; Days 30-90, 125-165 ng/mL (reduced) or 250-270 ng/mL (full); Days 90 through end of study, 95-145 ng/mL (reduced) or 190-220 ng/mL (full).

Other names: Neoral

Tacrolimus

Drug

Tacrolimus will be given as 1-mg and 5-mg capsules and dosed to maintain either reduced (Group A) or standard/full (Groups B and C) blood concentrations. Tacrolimus target concentrations are as follows: Days 1-30, 8-12 ng/mL; Days 30-90, 4-6 ng/mL (reduced), 8-10 ng/mL (full); Days 90 through end of study, 3-5 ng/mL (reduced), 6-8 ng/mL (full).

Other names: Prograf

Primary outcomes

  1. Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation

    Time frame: Month 12

  2. Percent Change from Baseline in Calculated Glomerular Filtration Rate (GFR) at 12 Months Post-Transplantation

    Time frame: Baseline to Month 12

Secondary outcomes

  1. Percentage of Participants with Treatment Failure During 6 and 20-24 Months Post-Transplantation

    Time frame: Months 6, 20-24

  2. Percentage of Participants with Biopsy-Proven Acute Rejection (BPAR)

    Time frame: Months 6, 12, 20-24

  3. Percentage of Participants by Number of BPAR Episodes

    Time frame: Months 6, 12, 20-24

  4. Percentage of Participants Treated for Acute Rejection (AR)

    Time frame: Months 6, 12, 20-24

  5. Percentage of Participants Who Experienced Graft Loss

    Time frame: Months 6, 12, 20-24

  6. Percentage of Participants Who Died

    Time frame: Months 6, 12, 20-24

  7. Percentage of Participants Who Discontinued Treatment with MMF

    Time frame: Months 6, 12, 20-24

  8. Time to First BPAR Episode

    Time frame: Months 6, 12, 20-24

  9. Time to Treatment Failure

    Time frame: Months 6, 12, 20-24

  10. Percent Change from Baseline in Calculated GFR at 3, 6, and 20-24 Months Post-Transplantation

    Time frame: Baseline to Months 3, 6, 20-24

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-Label, Prospective, Randomized, Controlled, Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept® Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 14, 2004
Registry last updated
Nov 7, 2016

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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