Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01758107
Recruitment Status : Unknown
Verified February 2015 by Natavudh Townamchai, MD, Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : January 1, 2013
Last Update Posted : February 3, 2015
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Renal Transplant Other: Withdraw cyclosporine Phase 4

Detailed Description:

Sirolimus with Cyclosporine minimization is the standard protocol for kidney transplantation in Chulalongkorn University. The investigators published the safety of this regimen in Transplantation Proceeding 2008; 40: 2206-8.

The investigators now further study in those patients who doing well with this regimen more than 1 year. The patients will be asked for kidney biopsy to evaluate and make sure they don't have subclinical rejection. The patients who don't have subclinical rejection will discontinue cyclosporine and continue with only sirolimus and prednisolone.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients
Study Start Date : August 2010
Actual Primary Completion Date : August 2013
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
Other: Withdraw cyclosporine
No Intervention: Sirolimus with Cyclosporine with Prednisolone

Primary Outcome Measures :
  1. longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Acute rejection rate [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • history of acute rejection, or subclinical rejection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01758107

Contact: Natavudh Townamchai, MD +66894904222

Chulalongkorn University Recruiting
Bangkok, Thailand
Contact: Natavudh Townamchai, MD    +66894904222   
Principal Investigator: Natavudh Townamchai, MD         
Sponsors and Collaborators
Chulalongkorn University

Responsible Party: Natavudh Townamchai, MD, MD, Chulalongkorn University Identifier: NCT01758107     History of Changes
Other Study ID Numbers: monorapa
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal