NCT00706680

Brief Summary

This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

3 active sites

Status
unknown

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

February 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 27, 2008

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

February 8, 2008

Last Update Submit

June 25, 2008

Conditions

DiabetesGraft Rejection

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test

    6 months post transplant.

Secondary Outcomes (1)

  • Incidence of acute rejection

    6 months post transplant

Study Arms (1)

1

EXPERIMENTAL

All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.

Drug: Thymoglobulin

Interventions

ThymoglobulinDRUG

methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days. Patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.

Also known as: Thymo, Polyclonal ATG, Methyl Prednisone, SoluMedrol, Steroid, Prednisone, MMF, Cell Cept, Mycophenolate Mofetil, Mycopnlolic Acid, Myfortic, Cyclosporine, Neoral
1

Eligibility Criteria

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

You may qualify if:

  • De Novo, single Kidney recipient
  • At least 1 HLA mismatch

You may not qualify if:

  • Recipient of multiple organs
  • prior transplant recipient
  • Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
  • PRA \>10%
  • Hepatitis B surface antigen positive
  • Hepatitis C antibody positive
  • HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St Paul's Hospital

Vancouver, British Columbia, V6Z 2E8, Canada

NOT YET RECRUITING

St Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

NOT YET RECRUITING

University health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Related Publications (1)

  • Cole EH, Prasad GV, Cardella CJ, Kim JS, Tinckam KJ, Cattran DC, Schiff JR, Landsberg DN, Zaltzman JS, Gill JS. A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients. Transplant Res. 2013 Jan 12;2(1):1. doi: 10.1186/2047-1440-2-1.

    PMID: 23369458DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

thymoglobulinMethylprednisolone HemisuccinateSteroidsPrednisoneMycophenolic AcidCyclosporine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsPregnadienediolsCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Edward Cole

    University Health Network, Toronto

    STUDY DIRECTOR

  • John Gill

    St. Paul's Hospital

    PRINCIPAL INVESTIGATOR

  • Ramesh Prasad

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward Cole

CONTACT

416-340-4800edward.cole@uhn.on.ca

Bricio Rodriguez

CONTACT

416-340-4800bricio.rodriguez@uhn.on.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2008

First Posted

June 27, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

June 27, 2008

Record last verified: 2008-02

Locations

CA(3)