Clinical Trials Logo
  1. Home
  2. Renal Transplant
  3. NCT01244659
  4. Details
NCT01244659 Clinical Trial

A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment

Renal Transplant Clinical Trial

Official title:
An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01244659
Other study ID # TACEMS0410
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date May 2014
Est. completion date December 2014

Study information
Verified date February 2021
Source EMS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 year old - Patient is receiving kidney from live or death donor - Kidney donor younger than 65 years old - PRA = 30% - Negative pregnancy test for women - Patient agreement to practice birth control - Patient has been fully informed and has given written informed consent Exclusion Criteria: - HLA identical - Patient multi-organ transplant recipient - Any pathology or past medical condition that can interfere with this protocol - Allergy or intolerance of any study medication

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus from EMS
Tacrolimus initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.
• Prograf
Prograf initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.

Locations
Country Name City State
Brazil Santa Casa de Misericórdia de Porto Alegre Porto Alegre RS

Sponsors (1)
Lead Sponsor Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy Incidence of biopsy confirmed acute rejection day 1 to day 180
Secondary Safety Patient and graft survival
Renal function control by Estimated Glomerular Filtration Rate
Safety, including incidence of post-transplant infection, malignances, diabetes mellitus, hepatotoxicity, blood pressure control and lipidic profile evaluation.		 day 1 to day 180
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 NCT02117596 - Calcineurin Inhibitor Based Immunosuppression Withdrawal N/A
Completed NCT00555373 - Pediatric Kidney Transplant Study of Sirolimus, Mycophenolate Mofetil, and Corticosteroids vs Calcineurin Inhibitor Based Immunosuppression 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