NCT00150085

Brief Summary

New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2004

Status
terminated

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
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
23 days 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
Last Updated

February 18, 2011

Status Verified

February 1, 2011

Enrollment Period

1.7 years

First QC Date

September 6, 2005

Last Update Submit

February 17, 2011

Conditions

Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients

Keywords

diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks

Secondary Outcomes (1)

  • Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks

Interventions

cyclosporine micro-emulsionDRUG

Eligibility Criteria

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

You may qualify if:

  • Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
  • Receiving tacrolimus as a primary immunosuppressant
  • Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus

You may not qualify if:

  • History of treated diabetes mellitus prior to transplantation
  • Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
  • Greater than 36 months post-transplantation
  • Onset of diabetes is greater than 12 months prior to time of study entry
  • Has unacceptable or unstable graft function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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 6, 2005

First Posted

September 8, 2005

Study Start

February 1, 2004

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 18, 2011

Record last verified: 2011-02