NCT00312143

Brief Summary

This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2004

Status
completed

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

February 1, 2004

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 7, 2006

Completed
Last Updated

February 2, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

April 5, 2006

Last Update Submit

February 1, 2011

Conditions

De Novo Kidney Transplant Recipients

Keywords

De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium

Outcome Measures

Primary Outcomes (3)

  • patient and graft survival

  • acute rejection incidence

  • graft function at 6 months post transplant.

Secondary Outcomes (1)

  • influence of age, gender, and post-transplantation complications on the main clinical outcomes

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 to 75 years.
  • Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
  • Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

You may not qualify if:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
  • Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
  • Patients with low platelet count (\< 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.
  • Patients who have received an investigational drug within four weeks prior to study entry.
  • Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
  • Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

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

April 5, 2006

First Posted

April 7, 2006

Study Start

February 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 2, 2011

Record last verified: 2011-02