A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

NCT01292226 | Completed Phase 2 Results

• 1 other identifier: ML19835
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

Brief Summary

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Acute Rejection

  Diagnosis of acute rejection was suspected in any participant with an increase in serum creatinine greater than or equal to (≥) 25 percent (%). All suspected acute rejections were confirmed by biopsy. The start date of acute rejection was identified as the date of biopsy.

  Day 1, Weeks 2, 4, 12, 24, and 28

• Time to Rejection

  The mean time, in days, from the date of enrollment to date of biopsy confirming acute rejection.

  Day 1, Weeks 2, 4, 12, 24, and 28

• Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)

  BPAR was defined according to 1997 Banff Criteria as a biopsy Banff grade of IA, IB, IIA, IIB, or III. Grade IA was defined as significant interstitial infiltration with greater than (\>)25% of parenchyma affected, and foci of moderate tubulitis with \>4 mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IB was defined as significant interstitial infiltration with \>25% parenchyma affected, and foci of severe tubulitis with \>10% mononuclear cells per tubular cross section or group of 10 tubular cells. Grade IIA was defined as mild to moderate intimal arteritis. Grade IIB was defined as severe intimal arteritis comprising \>25% of the luminal area. Grade III was defined as transmural arteritis and/or arterial fibrinoid changes and necrosis of medial smooth muscle cells.

  Day 1, Weeks 2, 4, 12, 24, and 28

Secondary Outcomes (25)

• Percentage of Participants With Graft Loss

  Day 1, Weeks 2, 4, 12, 24, and 28

• Percentage of Participants Surviving

  Day 1, Weeks 2, 4, 12, 24, and 28

• Total Mycophenolate Acid (MPA) by Visit and Timepoint

  Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits

• Free MPA (mcg/mL) by Visit

  Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits

• MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit

  Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)

Study Arms (1)

Mycophenolate Mofetil Monotherapy

EXPERIMENTAL

Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.

Drug: mycophenolate mofetil; Drug: antibody induction; Drug: Cyclosporine; Drug: corticosteroid

Interventions

mycophenolate mofetil DRUG

1 g PO BID for 24 weeks

Also known as: CellCept

Mycophenolate Mofetil Monotherapy

antibody induction DRUG

According to manufacturer recommendation

Mycophenolate Mofetil Monotherapy

Cyclosporine DRUG

According to manufacturer recommendation

Mycophenolate Mofetil Monotherapy

corticosteroid DRUG

According to manufacturer recommendation

Mycophenolate Mofetil Monotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, 18 to 65 years of age
• Patients undergoing primary kidney transplantation

You may not qualify if:

• Recipients of multiple organ transplants
• Prior therapy with CellCept
• Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
• Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Bari, 70124, Italy

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Coppito, 67100, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

Unknown Facility

Verona, 37126, Italy

Location

MeSH Terms

Interventions

Mycophenolic Acid; Cyclosporine; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; 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 CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 9, 2011
• Study Start: December 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 12, 2016
• Results First Posted: March 2, 2015

Record last verified: 2016-04

Locations

IT (7)