NCT00983645

Brief Summary

This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Longer than P75 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

October 1, 2004

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

October 20, 2015

Completed
Last Updated

June 3, 2016

Status Verified

April 1, 2016

Enrollment Period

8 years

First QC Date

September 23, 2009

Results QC Date

September 17, 2015

Last Update Submit

April 28, 2016

Conditions

Renal Transplant Rejection

Keywords

Kidney TransplantationImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Rejection

    6 months post-transplant

Secondary Outcomes (3)

  • Renal Function

    6 months post-transplant

  • Post-transplant Diabetes Mellitus

    6 months post-transplant

  • Lipid Levels

    6 months post-transplant

Study Arms (2)

Neoral

ACTIVE COMPARATOR

Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants

Drug: Neoral

Prograf

ACTIVE COMPARATOR

Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.

Drug: Prograf

Interventions

PrografDRUG

Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID

Also known as: Tacrolimus
Prograf
NeoralDRUG

Cyclosporine (Neoral) starting dose 3mg/kg PO BID

Also known as: Cyclosporine
Neoral

Eligibility Criteria

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

You may qualify if:

  • Cadaveric or Living Donors
  • years old or greater
  • Primary renal transplants
  • Hispanic ethnicity

You may not qualify if:

  • Prior renal transplant
  • Multi-organ transplant
  • Recipient with history of Diabetes Mellitus
  • PRA \> 20%
  • Cold Ischemia Time \> 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Related Publications (5)

  • Neylan JF. Racial differences in renal transplantation after immunosuppression with tacrolimus versus cyclosporine. FK506 Kidney Transplant Study Group. Transplantation. 1998 Feb 27;65(4):515-23. doi: 10.1097/00007890-199802270-00011.

    PMID: 9500626BACKGROUND

  • First MR, Gerber DA, Hariharan S, Kaufman DB, Shapiro R. Posttransplant diabetes mellitus in kidney allograft recipients: incidence, risk factors, and management. Transplantation. 2002 Feb 15;73(3):379-86. doi: 10.1097/00007890-200202150-00011.

    PMID: 11884934BACKGROUND

  • Jindal RM, Hjelmesaeth J. Impact and management of posttransplant diabetes mellitus. Transplantation. 2000 Dec 15;70(11 Suppl):SS58-63. No abstract available.

    PMID: 11152233BACKGROUND

  • Knoll GA, Bell RC. Tacrolimus versus cyclosporin for immunosuppression in renal transplantation: meta-analysis of randomised trials. BMJ. 1999 Apr 24;318(7191):1104-7. doi: 10.1136/bmj.318.7191.1104.

    PMID: 10213717BACKGROUND

  • Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.

    PMID: 9112351BACKGROUND

MeSH Terms

Interventions

TacrolimusCyclosporine

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

A limitation to this study is early termination leading to a small number of subjects.

Results Point of Contact

Title
Dr. Pedro Baron
Organization
Loma Linda University Medical Center Transplantation Institute
pbaron@llu.edu
909-558-3636

Study Officials

  • Pedro Baron, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 24, 2009

Study Start

October 1, 2004

Primary Completion

October 1, 2012

Study Completion

March 1, 2013

Last Updated

June 3, 2016

Results First Posted

October 20, 2015

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)