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

NCT00758602 | Completed Phase 4 Results

• 1 other identifier: ML21740
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 6

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

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

  Months 6 and 12

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

  BL, Weeks 2, 4, 13, 26, 39, and 52

• Time to First Acute Rejection Post-Transplant

  BL, Weeks 2, 4, 13, 26, 39, and 52

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

  Month 12

• Participant and Graft Survival

  Months 6 and 12

Study Arms (2)

MMF, Standard Dose Tacrolimus

ACTIVE COMPARATOR

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.

Drug: mycophenolate mofetil; Drug: tacrolimus, standard dose; Drug: corticosteroids

MMF, Low Dose Tacrolimus

EXPERIMENTAL

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.

Drug: mycophenolate mofetil; Drug: tacrolimus, low dose; Drug: corticosteroids

Interventions

mycophenolate mofetil DRUG

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

Also known as: CellCept

MMF, Low Dose Tacrolimus; MMF, Standard Dose Tacrolimus

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.

MMF, Standard Dose Tacrolimus

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.

MMF, Low Dose Tacrolimus

corticosteroids DRUG

According to center's practice

MMF, Low Dose Tacrolimus; MMF, Standard Dose Tacrolimus

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Beijing, 100020, China

Location

Unknown Facility

Fuzhou, 350025, China

Location

Unknown Facility

Guangzhou, 510080, China

Location

Unknown Facility

Nanjing, 210008, China

Location

Unknown Facility

Shanghai, 200025, China

Location

Unknown Facility

Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Mycophenolic Acid; Tacrolimus; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Macrolides; Lactones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

CN (6)