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

Kidney Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087581
• Other study ID #: ML17225
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2004
• Last updated: November 3, 2016
• Start date: June 2004
• Est. completion date: September 2007

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Mycophenolate mofetil
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.
• Cyclosporine
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).
• Tacrolimus
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Treatment Failure During 12 Months Post-Transplantation		Month 12	No
Primary	Percent Change from Baseline in Calculated Glomerular Filtration Rate (GFR) at 12 Months Post-Transplantation		Baseline to Month 12	No
Secondary	Percentage of Participants with Treatment Failure During 6 and 20-24 Months Post-Transplantation		Months 6, 20-24	No
Secondary	Percentage of Participants with Biopsy-Proven Acute Rejection (BPAR)		Months 6, 12, 20-24	No
Secondary	Percentage of Participants by Number of BPAR Episodes		Months 6, 12, 20-24	No
Secondary	Percentage of Participants Treated for Acute Rejection (AR)		Months 6, 12, 20-24	No
Secondary	Percentage of Participants Who Experienced Graft Loss		Months 6, 12, 20-24	No
Secondary	Percentage of Participants Who Died		Months 6, 12, 20-24	No
Secondary	Percentage of Participants Who Discontinued Treatment with MMF		Months 6, 12, 20-24	No
Secondary	Time to First BPAR Episode		Months 6, 12, 20-24	No
Secondary	Time to Treatment Failure		Months 6, 12, 20-24	No
Secondary	Percent Change from Baseline in Calculated GFR at 3, 6, and 20-24 Months Post-Transplantation		Baseline to Months 3, 6, 20-24	No