NCT00154206

Brief Summary

The aim of this pilot study is to evaluate efficacy and tolerability of EC-MPS b.i.d, with Cyclosporine microemulsion and steroids in pediatric de novo renal transplant patients. Safety and doses variations are also evaluated.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

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

September 1, 2004

Completed
1 year 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

2.3 years

First QC Date

September 8, 2005

Last Update Submit

February 22, 2017

Conditions

Kidney Transplantation

Keywords

Enteric-coated mycophenolate sodium,de novo,renal transplantation,pediatricDe novo pediatric renal transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of biopsy-proven-acute-rejection and treatment failure (defined by graft loss and/or biopsy-proven-acute-rejection and/or death and/or lost to follow-up and/or study discontinuation) within the 6 and 12 months post transplantation

Secondary Outcomes (7)

  • Within the 6 and 12 months post transplantation

  • Incidence of acute rejection resistant to steroids

  • Incidence of graft loss and death

  • Renal function by creatinine and creatinine clearance (Schwartz formula)

  • Incidence of premature study drug discontinuation due to safety reason

  • +2 more secondary outcomes

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Recipients of a primary renal transplantation
  • Recipients of a renal transplantation only

You may not qualify if:

  • Recipients of a multi-organ transplantation
  • Unable to take an oral medication
  • Requiring an induction therapy with polyclonal, monoclonal antibodies (OKT3, ATG, ALG).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • Niaudet P, Charbit M, Loirat C, Lapeyraque AL, Tsimaratos M, Cailliez M, Foulard M, Dehennault M, Marquet P, Chaouche-Teyara K, Lemay D. Enteric-coated mycophenolate sodium in de novo pediatric renal transplant patients. Pediatr Nephrol. 2009 Feb;24(2):395-402. doi: 10.1007/s00467-008-1031-7. Epub 2008 Nov 5.

    PMID: 18985393BACKGROUND

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Primary Completion

January 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

CH(1)