NCT00154245

Brief Summary

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

September 8, 2005

Last Update Submit

February 21, 2017

Conditions

Kidney Transplantation

Keywords

Enteric-coated mycophenolate sodium, transplantation, de novo, cyclosporine

Outcome Measures

Primary Outcomes (1)

  • Graft function 6 months post transplantation

Secondary Outcomes (5)

  • Incidence of biopsy proven acute rejection, graft loss or death within 6 and 12 months post transplantation

  • Incidence of biopsy proven acute rejection within 6 and 12 months post transplantation

  • Time to first biopsy-proven acute rejection

  • Severity of biopsy-proven acute rejection

  • Graft survival and patient survival at 6 and 12 months

Interventions

Enteric-Coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants

You may not qualify if:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
  • Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.
  • Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).
  • Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, other components of the formulation (e.g. lactose).
  • Patients with thrombocytopenia (75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02