Renal TransplantationPhase 4SINGLENCT01742676
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
A Phase 4 study testing ADVAGRAF and PROGRAF in people with Renal Transplantation and Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Transplantation, Kidney Transplantation, Stable Renal Recipients
- What is being tested?
- ADVAGRAF and PROGRAF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients who meet the following inclusion criteria should be enrolled.
- 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
Who cannot join
- 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
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- 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
- Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- ADVAGRAF, PROGRAF
- Keywords
- tacrolimus, kidney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVAGRAFDrug
Also called modified release tacrolimus
oral
PROGRAFDrug
Also called twice-daily tacrolimus
oral
| Study group | Role | What they receive |
|---|---|---|
| ADVAGRAF group | Experimental | Not described Receives: Drug: ADVAGRAF |
| PROGRAF group | Active comparator | Not described Receives: Drug: PROGRAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: at 24 weeks
Secondary outcomes (5)
Glomerular Filtration Rate (GFR)
Calculated by Modification of Diet in Renal Disease equation
Measured: at 24 weeks
Incidence of rejection reactions
Measured: at 24 weeks
Blood pressure
Measured: at 24 weeks
Survival rate of the grafts
Measured: at 24 weeks
Subject's physical condition (SF-35)
Evaluation of subject's physical condition
Measured: at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742676
- Sponsor's protocol ID
- ADV-KT-03
- Acronym
- SINGLE
- Status last verified
- Aug 2014
- First submitted
- 4 Dec 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01742676
- Acronym / sponsor ID
- SINGLE / ADV-KT-03
- Keywords
- tacrolimus, kidney
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADVAGRAF group | Experimental | Drug: ADVAGRAF |
| PROGRAF group | Active comparator | Drug: PROGRAF |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Only patients who meet the following inclusion criteria should be enrolled.
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADVAGRAFAlso: modified release tacrolimusoral | Drug | ADVAGRAF group |
| PROGRAFAlso: twice-daily tacrolimusoral | Drug | PROGRAF group |
Primary outcome
Incidence of adverse events
Time frame: at 24 weeks
5 secondary outcomes
Glomerular Filtration Rate (GFR)
Time frame: at 24 weeks
Incidence of rejection reactions
Time frame: at 24 weeks
Blood pressure
Time frame: at 24 weeks
Survival rate of the grafts
Time frame: at 24 weeks
Subject's physical condition (SF-35)
Time frame: at 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADVAGRAF and PROGRAF in people with Renal Transplantation and Kidney Transplantation, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.