NCT00238992

Brief Summary

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug. The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

November 2, 2011

Status Verified

November 1, 2011

Enrollment Period

2.6 years

First QC Date

October 12, 2005

Last Update Submit

November 1, 2011

Conditions

Kidney de Novo Transplant

Keywords

Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine

Outcome Measures

Primary Outcomes (1)

  • biopsy proven acute rejection incidence at 1 year post-transplantation

Secondary Outcomes (7)

  • Incidence of biopsy proven acute rejection episodes at 6 months

  • Incidence of treated rejection episodes at 6 months and 1 year

  • Incidence of steroid-resistant episodes at 6 months and 1 year

  • Patient and graft survival at 1 year

  • Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)

  • +2 more secondary outcomes

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients undergoing first kidney transplant.
  • Patients aged 18 -70 years.

You may not qualify if:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  • Positive HBsAg test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

December 1, 2002

Primary Completion

July 1, 2005

Last Updated

November 2, 2011

Record last verified: 2011-11