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Completed

NCT Number: NCT00758602

A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

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Key information

Conditions

Kidney Transplantation

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, <=75 years of age;
  • single organ recipients of renal allograft;
  • negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Exclusion criteria

  • severe gastrointestinal disease which may influence the absorption of oral drug therapy;
  • severe infection, HIV or active hepatitis;
  • active gastric ulcers;
  • malignancy other than cured skin cancer;
  • severe anemia, leucopenia or thrombocytopenia.

Treatment and study plan

Mycophenolate mofetil

Drug

0.75-1 g PO BID from Day 0 through Month 12

Other names: CellCept

tacrolimus, standard dose

Drug

Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.

tacrolimus, low dose

Drug

Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.

Corticosteroids

Drug

According to center's practice

Primary outcomes

  1. Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation

    Time frame: Month 12

    CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (>)50% cell infiltration); interstitial fibrosis (0=none, 1=~25% interstitial affected, 2=26-50% interstitial affected, and 3=>50% interstitial affected); tubular atrophy (0=none, 1=~15% proximal tubular atrophy [PTA], 2=16-30% PTA, and 3=>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis [NGS] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (<)25% remaining artery/small artery membrane [RA/SAM], 2=EP to 26-50% [RA/SAM], and 3=>50% [RA/SAM]). CADI score was the sum of the 6 histological findings.

  2. Glomerular Filtration Rate (GFR) at Month 12 After Transplantation

    Time frame: Month 12

    GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kg) divided by [72 * serum creatinine mg per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)].

Secondary outcomes

  1. Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant

    Time frame: Months 6 and 12

  2. Time to First Acute Rejection Post-Transplant - Number of Participants With an Event

    Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52

  3. Time to First Acute Rejection Post-Transplant

    Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52

    The median time, in days, between randomization and acute rejection.

  4. Percentage of Participants With Treatment Failure at 12 Months Post-Transplant

    Time frame: Month 12

    Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.

  5. Participant and Graft Survival

    Time frame: Months 6 and 12

    The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.

  6. Serum Creatinine (Micromoles Per Liter [µmol/L])

    Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52

    The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.

  7. Glomerular Filtration Rate (GFR) (mL/Min)

    Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52

    The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 25, 2008
Registry last updated
Aug 4, 2014

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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