A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients

Kidney Transplantation Clinical Trial

— SINGLE  

Official title:

A Single Center, Open-label, Randomized Pilot Study to Evaluate the Safety and Efficacy of Modified-release Tacrolimus, ADVAGRAF®, Versus Those of Twice-daily Tacrolimus, PROGRAF®, in Stable Renal Recipients (SINGLE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742676
• Other study ID #: ADV-KT-03
• Status: Completed
• Phase: Phase 4
• First received: December 4, 2012
• Last updated: August 4, 2014
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Only patients who meet the following inclusion criteria should be enrolled.

1. Patients who received a kidney at least within 12 months of their study enrollment (from a deceased or living donor)

2. Patients whose tacrolimus dose have not been changed in at least 12 weeks from their study enrollment and whose minimum blood tacrolimus concentration mean value is within 3-10 ng/ml

3. Female patients who showed a negative result in the serum pregnancy test and who agreed to use an effective contraceptive method during the study period

4. Patients who are clinically stable based on the judgment of the investigator

5. Patients who were given enough information regarding the study, understood the objectives and risks of the study, and signed the informed consent form

Exclusion Criteria:

Patients who fall under any of the following criteria should not be enrolled in this study.

1. Patients who had received any other organ except a kidney

2. Patients who showed an acute rejection reaction within 12 weeks of their enrollment or who showed an acute rejection reaction that required antilymphocyte antibody therapy within 24 weeks

3. Patients who were diagnosed with a newly developed malignant tumor (Patients with successfully treated squamous cell/basal cell carcinoma can be enrolled, though.)

4. Patients who have a known allergy to the investigational drug (the test/control drug) or to tacrolimus

5. Patients who have an unstable medical condition that may affect the evaluation of the study's objectives based on the investigator's judgment

6. Patients who have any form of drug abuse or mental illness that might complicate communication with the investigators based on the investigator's judgment

7. Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment

8. Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment

9. Patients who are pregnant or breastfeeding

10. Patients who had been HIV-positive

11. Patients who are considered non-compliant with the scheduled study visits in the protocol

12. Patients who have abnormal kidney functions or a serum creatinine level higher than 1.6 mg/dL/GFR (MDRD) or less than 30 mL/min at the screening visit

13. Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment)

14. Patients who have abnormal liver functions: i.e., whose SGPT/ALT and/or SGOT/AST and/or bilirubin is twice higher than the normal range in the center, and who have liver cirrhosis

15. Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN)

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Renal Transplantation
• Stable Renal Recipients

Intervention

Drug:
• ADVAGRAF
oral
• PROGRAF
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		at 24 weeks	No
Secondary	Glomerular Filtration Rate (GFR)	Calculated by Modification of Diet in Renal Disease equation	at 24 weeks	No
Secondary	Incidence of rejection reactions		at 24 weeks	No
Secondary	Blood pressure		at 24 weeks	Yes
Secondary	Survival rate of the grafts		at 24 weeks	No
Secondary	Subject's physical condition (SF-35)	Evaluation of subject's physical condition	at 24 weeks	No

External Links

•   Link to Results on JAPIC - enter 140524 in the JapicCTI-RNo. field