Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients

NCT00443937 | Completed Phase 4

• 1 other identifier: CRAD001ADE05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are

• To determine the influence of CNI discontinuation on the drug exposure and key pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium (EC-MPS)
• To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen
• To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety (e.g. rejection rates) and tolerability
• To investigate renal function after CsA withdrawal

Conditions

Renal Transplantation

Keywords

Kidney Transplantation; Renal Transplantation; Mycophenolate; Cyclosporine; Everolimus

Outcome Measures

Primary Outcomes (2)

• Kinetic Profiles (MPA, everolimus, and optional IMPDH) will be measured at day 0, 7 and 7 days after complete removal of CsA and last dose adjustment of everolimus due to trough level outside target range

  7 days

• Everolimus trough level will be measured at day 7, 14, 21, 28 and month 2, 4, 6, 9, 12

  1 year

Secondary Outcomes (3)

• Safety and tolerability of the treatment regimen consisting over a one year period

  1 year

• Renal function during the course of the trial, especially after CNI withdrawal.

  1 year

• Routine laboratory parameters during the course of the trial.

  1 year

Interventions

enteric-coated mycophenolate sodium DRUG

oral

Also known as: Myfortic

everolimus DRUG

oral

Also known as: Certican

Eligibility Criteria

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

You may qualify if:

• Patients having a kidney transplant since at least 6 months but for no longer than 5 years.
• Patients in a stable condition in terms of graft function
• Patients currently receiving EC-MPS and CsA with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month prior to Baseline

You may not qualify if:

• Patients with any known hypersensitivity to EC-MPS or everolimus or other components of the formulation (e.g., lactose)
• Patients with a history of severe rejection (according to BANFF criteria) within 3 months of enrollment in this trial.
• Changes to the immunosuppressive regimen during the last 3 months due to immunologic reasons.
• Patients with thrombocytopenia (platelets \<100,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (leukocytes \<4,500/mm3), and/or hemoglobin \<9.0 g/dL at baseline.
• Patients with proteinuria at baseline (\> 1g/d)

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Novartis: collaborator

Study Sites (1)

Charité-Universitätsmedizin

Berlin, 10117, Germany

Location

MeSH Terms

Interventions

Mycophenolic Acid; Everolimus

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Sirolimus; Macrolides; Lactones

Study Officials

• Klemens Budde, Prof.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 7, 2007
• Study Start: January 1, 2004
• Study Completion: March 1, 2006
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

DE (1)