NCT00217152

Brief Summary

This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

2.4 years

First QC Date

September 20, 2005

Last Update Submit

December 16, 2011

Conditions

Kidney TransplantationDelayed Graft Function

Keywords

Kidney Transplant

Outcome Measures

Primary Outcomes (2)

  • Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up

    during the first 12 months following randomization

  • Assessment of renal function

    12 months post randomization

Secondary Outcomes (5)

  • The proportion of patients experiencing biopsy proven acute rejections

  • The total number of biopsy proven, acute rejection episodes, per patient

  • The proportion of patients treated for acute rejection

  • The time to the first proven acute rejection

  • The time to the treatment failure

Interventions

CellCeptDRUG

Eligibility Criteria

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

You may qualify if:

  • Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Delayed Graft Function

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Mark D. Stegall, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

US(1)