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Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2015 by Natavudh Townamchai, MD, Chulalongkorn University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758107
First Posted: January 1, 2013
Last Update Posted: February 3, 2015
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.
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University
  Purpose
Study safety of longterm immunosuppressive protocol with Sirolimus plus Prednisolone, and Calcineurin inhibitor withdrawal.

Condition Intervention Phase
Renal Transplant Other: Withdraw cyclosporine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Natavudh Townamchai, MD, Chulalongkorn University:

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

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

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: October 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sirolimus with Prednisolone
Sirolimus with Prednisolone, and withdraw cyclosporine
Other: Withdraw cyclosporine
No Intervention: Sirolimus with Cyclosporine with Prednisolone

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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • history of acute rejection, or subclinical rejection
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01758107


Contacts
Contact: Natavudh Townamchai, MD +66894904222 ntownamchai@gmail.com

Locations
Thailand
Chulalongkorn University Recruiting
Bangkok, Thailand
Contact: Natavudh Townamchai, MD    +66894904222    ntownamchai@gmail.com   
Principal Investigator: Natavudh Townamchai, MD         
Sponsors and Collaborators
Chulalongkorn University
  More Information

Responsible Party: Natavudh Townamchai, MD, MD, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01758107     History of Changes
Other Study ID Numbers: monorapa
First Submitted: December 25, 2012
First Posted: January 1, 2013
Last Update Posted: February 3, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Prednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antiemetics