NCT01758107

Brief Summary

Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

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

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

August 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 3, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

December 25, 2012

Last Update Submit

February 1, 2015

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

  • longterm glomerular filtration rate defined by eGFR CKD-EPI

    5 years

Secondary Outcomes (1)

  • Acute rejection rate

    5 years

Study Arms (2)

Sirolimus with Prednisolone

EXPERIMENTAL

Sirolimus with Prednisolone, and withdraw cyclosporine

Other: Withdraw cyclosporine

Sirolimus with Cyclosporine with Prednisolone

NO INTERVENTION

Interventions

Withdraw cyclosporineOTHER
Sirolimus with Prednisolone

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant with Sirolimus plus Cyclosporine plus Prednisolone more than 1 year

You may not qualify if:

  • history of acute rejection, or subclinical rejection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, Thailand

RECRUITING

Central Study Contacts

Natavudh Townamchai, MD

CONTACT

+66894904222ntownamchai@gmail.com

Study Design

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

Study Record Dates

First Submitted

December 25, 2012

First Posted

January 1, 2013

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

October 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-02

Locations

TH(1)