NCT00352092

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a steroid-free and calcineurin-inhibitor free treatment regimen for patients who are receiving a kidney transplant from a living donor that is HLA-identical (has a similar immune system).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_4

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

June 1, 2002

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

5.5 years

First QC Date

July 13, 2006

Last Update Submit

November 12, 2014

Conditions

Renal Transplant

Keywords

Kidney diseaseRenal transplantHLA IdenticalLiving DonorCorticosteroid freeCalcineurin sparingAdults

Outcome Measures

Primary Outcomes (1)

  • Incidence of biopsy confirmed acute rejection at 12 and 24 months.

Secondary Outcomes (11)

  • Patient survival

  • Graft survival

  • Early discontinuation of mycophenolate mofetil, tacrolimus, or sirolimus due to toxicity

  • Time to acute rejection from transplant

  • Severity of acute rejection measure by Banff'93 criteria, and/or requirement of antilymphocyte treatment; need for corticosteroid pulse or maintenance therapy for rejection or recurrent disease

  • +6 more secondary outcomes

Interventions

calcineurin inhibitorDRUG
sirolimusDRUG
mycophenolate mofetilDRUG

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 70 years
  • Male/female recipients
  • All ethnic groups
  • Negative pregnancy test
  • Practicing an acceptable form of birth control
  • Signing informed consent

You may not qualify if:

  • Known sensitivity or contraindication to mycophenolate mofetil, tacrolimus, or sirolimus
  • Re-transplants who lost primary transplant from immunologic causes (patients with graft loss secondary to technical or calcineurin-inhibitor toxicity will be included)
  • Liver, heart, pancreas or small bowel transplant recipient
  • Fasting total cholesterol \>300 mg/dL and fasting triglycerides \>400 mg/dL
  • Baseline WBC count \<3000/cu.mm
  • Baseline platelet count \<100,000/cu.mm
  • Known or suspected malignancy within previous 3 years, (Patients with squamous cell and basal skin cancer are not excluded)
  • Active systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

Calcineurin InhibitorsSirolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Rita Alloway, Pharm.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

June 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

US(1)