NCT00306397

Brief Summary

The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

June 30, 2010

Status Verified

June 1, 2010

Enrollment Period

3.4 years

First QC Date

March 22, 2006

Last Update Submit

June 29, 2010

Conditions

Kidney Transplantation

Keywords

Kidney transplantationSteroid freeCalcineurin inhibitor freeTacrolimusSirolimus

Outcome Measures

Primary Outcomes (1)

  • Allograft function

    6 months

Secondary Outcomes (3)

  • Patients successfully withdrawn from calcineurin inhibitor after three months

    3 months

  • Graft survival

    6 months

  • Patient survival

    6 months

Study Arms (2)

A

ACTIVE COMPARATOR

Rapamycin - MMF after 3 months

Drug: Rapamycin

B

ACTIVE COMPARATOR

Low dose tacrolimus - MMF - Rapamycin after 3 months

Drug: Rapamycin

Interventions

RapamycinDRUG

Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -

Also known as: Sirolimus, Rapammune
AB

Eligibility Criteria

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

You may qualify if:

  • adult patients with end stage kidney disease suitable for primary renal transplantation or retransplantation
  • patients receiving a graft from a living related, living unrelated or brain-death donor

You may not qualify if:

  • patients with a low or high immunological risk constellation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel, Clinic for Transplantation Immunology and Nephrology

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Juerg U Steiger, MD

    University Hospital Basel, Clinic for Transplantation Immunology and Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 23, 2006

Study Start

January 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

June 30, 2010

Record last verified: 2010-06

Locations

CH(1)