This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (\*) height (h)/ liter(L).
2 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52.
Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
Unnamed facility
Bordeaux, France
Unnamed facility
Brest, France
Unnamed facility
Clermont-Ferrand, France
Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.
Time frame: Week 12
Serum Creatinine Values [Micromoles Per Liter (µmol/L)]
The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.
Time frame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])
The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.
Time frame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation
The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters \[m\^2\]) =186 multiplied by (\*) serum creatinine in mg/L raised to the power of (\^) -1.154 \* age \^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m\^2) = males formula \* 0.742.
Time frame: Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
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500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7.
100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52
Unnamed facility
Créteil, France
Unnamed facility
Dijon, France
Unnamed facility
La Tronche, France
Unnamed facility
Le Kremlin-Bicêtre, France
Unnamed facility
Lille, France
Unnamed facility
Limoges, France
Unnamed facility
Montpellier, France
...and 14 more locations
Time frame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Time to Occurrence of First BPAR Between Day 0 and Week 52
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Percentage of Participants With at Least One BPAR at Week 12 and Week 52
BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Weeks 12 and 52
Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52
Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Weeks 12 and 52
Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52
Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Weeks 12 and 52
Graft Loss - Percentage of Participants With an Event
Graft loss was defined as physical loss (nephrectomy), functional loss \[necessitating maintenance dialysis for greater than (\>)8 weeks\], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Time to Graft Loss
The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52
Participant Survival
Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.
Time frame: Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52