NCT00229138

Brief Summary

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2005

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, 2005

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

September 27, 2005

Last Update Submit

February 3, 2017

Conditions

Kidney Transplantation

Keywords

De novo kidney recipients,EC-MPS,tacrolimus,efficacy,safety,glomerular filtration rateTreatment in de novo kidney recipients

Outcome Measures

Primary Outcomes (1)

  • renal function at 6 months posttransplant as measured by glomerular filtration rate

    6 months

Secondary Outcomes (7)

  • Efficacy as measured by combined incidence of biopsy proven acute rejection episodes, graft loss, and death at 6 months

  • Renal function as measured by calculated creatinine clearance

  • Cockcroft-Gaultand serum creatinine at 6 months

  • Gastrointestinal tolerability as measured by gastrointestinal

  • symptom rating scale (GSRS) at various time points

  • +2 more secondary outcomes

Study Arms (2)

reduced Tacrolimus

EXPERIMENTAL
Drug: EC-MPS, Tacrolimus

Reference Tacrolimus

ACTIVE COMPARATOR
Drug: EC-MPS, Tacrolimus

Interventions

EC-MPS, TacrolimusDRUG
Reference Tacrolimusreduced Tacrolimus

Eligibility Criteria

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

You may qualify if:

  • Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
  • The renal cold ischemic time (CIT) must be \<30 hours
  • The age of the donor must be between 10 and 65 years

You may not qualify if:

  • Patients who have previously received an organ transplant
  • Patients who are recipients of a multiple organ transplants
  • Recipients of non heart-beating donor organs
  • ABO incompatibility against the donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Chan L, Andres A, Bunnapradist S, Gugliuzza K, Parasuraman R, Peddi VR, Cassuto E, Hart M. Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS. J Transplant. 2012;2012:941640. doi: 10.1155/2012/941640. Epub 2012 Nov 25.

    PMID: 23227307RESULT

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)