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

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ClinicalTrials.gov Identifier: NCT00758602
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 25, 2008
Results First Submitted Date  ICMJE July 8, 2014
Results First Posted Date  ICMJE August 4, 2014
Last Update Posted Date August 4, 2014
Study Start Date  ICMJE September 2008
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • 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.
  • 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)].
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
Glomerular filtration rate; chronic allograft damage. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2014)
  • Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant [ Time Frame: Months 6 and 12 ]
  • Time to First Acute Rejection Post-Transplant - Number of Participants With an Event [ Time Frame: BL, Weeks 2, 4, 13, 26, 39, and 52 ]
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
  • Patient and graft survival; acute rejection episodes. [ Time Frame: Throughout study ]
  • AEs, laboratory parameters, renal disease, cardiovascular events, opportunistic infections, new onset of malignancies. [ Time Frame: Throughout study. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Transplantation
Intervention  ICMJE
  • Drug: mycophenolate mofetil
    0.75-1 g PO BID from Day 0 through Month 12
    Other Name: CellCept
  • Drug: tacrolimus, standard dose
    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.
  • Drug: tacrolimus, low dose
    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.
  • Drug: corticosteroids
    According to center's practice
Study Arms  ICMJE
  • Active Comparator: MMF, Standard Dose Tacrolimus
    Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (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. Participants also received corticosteroids per center practice.
    Interventions:
    • Drug: mycophenolate mofetil
    • Drug: tacrolimus, standard dose
    • Drug: corticosteroids
  • Experimental: MMF, Low Dose Tacrolimus
    Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 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 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. Participants also received corticosteroids per center practice.
    Interventions:
    • Drug: mycophenolate mofetil
    • Drug: tacrolimus, low dose
    • Drug: corticosteroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries Taiwan,   United States
 
Administrative Information
NCT Number  ICMJE NCT00758602
Other Study ID Numbers  ICMJE ML21740
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP