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

NCT01742676 | Completed Phase 4

• 1 other identifier: ADV-KT-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Transplantation; Kidney Transplantation; Stable Renal Recipients

Keywords

tacrolimus; kidney

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  at 24 weeks

Secondary Outcomes (5)

• Glomerular Filtration Rate (GFR)

  at 24 weeks

• Incidence of rejection reactions

  at 24 weeks

• Blood pressure

  at 24 weeks

• Survival rate of the grafts

  at 24 weeks

• Subject's physical condition (SF-35)

  at 24 weeks

Study Arms (2)

ADVAGRAF group

EXPERIMENTAL

Drug: ADVAGRAF

PROGRAF group

ACTIVE COMPARATOR

Drug: PROGRAF

Interventions

ADVAGRAF DRUG

oral

Also known as: modified release tacrolimus

ADVAGRAF group

PROGRAF DRUG

oral

Also known as: twice-daily tacrolimus

PROGRAF group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received a kidney at least within 12 months of their study enrollment (from a deceased or living donor)
• 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
• 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
• Patients who are clinically stable based on the judgment of the investigator
• Patients who were given enough information regarding the study, understood the objectives and risks of the study, and signed the informed consent form

You may not qualify if:

• Patients who fall under any of the following criteria should not be enrolled in this study.
• Patients who had received any other organ except a kidney
• 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
• Patients who were diagnosed with a newly developed malignant tumor (Patients with successfully treated squamous cell/basal cell carcinoma can be enrolled, though.)
• Patients who have a known allergy to the investigational drug (the test/control drug) or to tacrolimus
• Patients who have an unstable medical condition that may affect the evaluation of the study's objectives based on the investigator's judgment
• Patients who have any form of drug abuse or mental illness that might complicate communication with the investigators based on the investigator's judgment
• Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment
• Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment
• Patients who are pregnant or breastfeeding
• Patients who had been HIV-positive
• Patients who are considered non-compliant with the scheduled study visits in the protocol
• 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
• Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment)
• 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

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 5, 2012
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

KR (1)