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 (SINGLE)

August 4, 2014 updated by: Astellas Pharma Korea, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ADVAGRAF group
Drug: ADVAGRAF
oral
Other Names:
  • modified release tacrolimus
Active Comparator: PROGRAF group
Drug: PROGRAF
oral
Other Names:
  • twice-daily tacrolimus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: at 24 weeks
at 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glomerular Filtration Rate (GFR)
Time Frame: at 24 weeks
Calculated by Modification of Diet in Renal Disease equation
at 24 weeks
Incidence of rejection reactions
Time Frame: at 24 weeks
at 24 weeks
Blood pressure
Time Frame: at 24 weeks
at 24 weeks
Survival rate of the grafts
Time Frame: at 24 weeks
at 24 weeks
Subject's physical condition (SF-35)
Time Frame: at 24 weeks
Evaluation of subject's physical condition
at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Korea, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADV-KT-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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