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Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01758107
First received: December 25, 2012
Last updated: February 1, 2015
Last verified: February 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Chulalongkorn University:

Primary Outcome Measures:
  • longterm glomerular filtration rate defined by eGFR CKD-EPI [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 25, 2012
Last Updated: February 1, 2015
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Sirolimus
Cyclosporins
Cyclosporine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2016