Clinical Trials Logo
  1. Home
  2. Renal Transplant
  3. NCT01758107
  4. Details
NCT01758107 Clinical Trial

Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Renal Transplant Clinical Trial

Official title:
Study of Cyclosporine Withdrawal Regimen in Thai Renal Transplant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01758107
Other study ID # monorapa
Secondary ID
Status Recruiting
Phase Phase 4
First received December 25, 2012
Last updated February 1, 2015
Start date August 2010
Est. completion date October 2015

Study information
Verified date February 2015
Source Chulalongkorn University
Contact Natavudh Townamchai, MD
Phone +66894904222
Email ntownamchai@gmail.com
Is FDA regulated No
Health authority Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date October 2015
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 85 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- history of acute rejection, or subclinical rejection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Withdraw cyclosporine

Locations
Country Name City State
Thailand Chulalongkorn University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary longterm glomerular filtration rate defined by eGFR CKD-EPI 5 years No
Secondary Acute rejection rate 5 years Yes
See also
  Status Clinical Trial Phase
Completed NCT01220050 - Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism Phase 2
Completed NCT00820469 - Study of the Influence of Plasma Exchange on the Pharmacokinetics of Rituximab Phase 4
Completed NCT00239005 - Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation Phase 4
Completed NCT00270153 - The Use of ACE Inhibitors in the Early Renal Post-transplant Period Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT01256294 - Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients Phase 4
Suspended NCT01059292 - TIPE2 Associated With Kidney Transplant N/A
Completed NCT00547040 - Arterial Stiffness and Calcifications in Incident Renal Transplant Recipients
Suspended NCT03043339 - Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt
Completed NCT02581644 - Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries N/A
Completed NCT01728012 - Long-term Cardiovascular Risk Following Successful Renal Transplantation N/A
Terminated NCT01011114 - Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney Transplant N/A
Completed NCT00555373 - Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression N/A
Completed NCT02117596 - Calcineurin Inhibitor Based Immunosuppression Withdrawal N/A
Recruiting NCT05156086 - Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients
Completed NCT01334333 - Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients Phase 4
Recruiting NCT03107858 - The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function Phase 2/Phase 3
Completed NCT00352547 - Influence of Genes on Sirolimus Metabolism in Patients With Kidney Transplantation N/A