NCT00284921

Brief Summary

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2.3 years

First QC Date

January 30, 2006

Last Update Submit

November 1, 2011

Conditions

De Novo Kidney Transplant

Keywords

kidney transplant, hepatitis C, enteric-coated mycophenolate sodium

Outcome Measures

Primary Outcomes (1)

  • Hepatic function tests (ALT/AST) after 12 months treatment.

Secondary Outcomes (9)

  • Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.

  • Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.

  • Glomerular filtration rate and by proteinuria after 12 months treatment.

  • Graft survival after 12 months.

  • Incidence of AEs and SAEs after 3 and 12 months.

  • +4 more secondary outcomes

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
  • Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

You may not qualify if:

  • Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
  • Kidneys from non-heart beating donors.
  • ABO incompatibility against the donor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2006

First Posted

February 1, 2006

Study Start

April 1, 2004

Primary Completion

August 1, 2006

Last Updated

November 2, 2011

Record last verified: 2011-11