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

Kidney Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758602
• Other study ID #: ML21740
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: July 8, 2014
• Start date: September 2008
• Est. completion date: February 2011

Study information

• Verified date: July 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Fodd and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

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
0.75-1 g PO BID from Day 0 through Month 12
• 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.
• 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.
• corticosteroids
According to center's practice

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation	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.	Month 12	No
Primary	Glomerular Filtration Rate (GFR) at Month 12 After Transplantation	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)].	Month 12	No
Secondary	Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant		Months 6 and 12	No
Secondary	Time to First Acute Rejection Post-Transplant - Number of Participants With an Event		BL, Weeks 2, 4, 13, 26, 39, and 52	No
Secondary	Time to First Acute Rejection Post-Transplant	The median time, in days, between randomization and acute rejection.	BL, Weeks 2, 4, 13, 26, 39, and 52	No
Secondary	Percentage of Participants With Treatment Failure at 12 Months Post-Transplant	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.	Month 12	No
Secondary	Participant and Graft Survival	The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.	Months 6 and 12	No
Secondary	Serum Creatinine (Micromoles Per Liter [µmol/L])	The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.	BL, Weeks 2, 4, 13, 26, 39, and 52	No
Secondary	Glomerular Filtration Rate (GFR) (mL/Min)	The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.	BL, Weeks 2, 4, 13, 26, 39, and 52	No