the Maintenance Phase After Kidney TransplantationNCT02160054
Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)
An observational study of the Maintenance Phase After Kidney Transplantation, run by Astellas Pharma Inc at 30 sites in Japan.
Trial summary
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- the Maintenance Phase After Kidney Transplantation
- What is being tested?
- Graceptor®
- Type of treatment
- Pill or oral medicine
- How many people
- 289 participants
- Where
- 30 sitesJapan
- Study dates
- 15 Nov 2013to 31 Mar 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
Who may be able to join
- Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
- Patients who meet one or more of following criteria
- Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision
- Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug
- Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug
- Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision
- Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision
Who cannot join
None listed.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Japan30 sites
Site JP00001
Aichi
Site JP00015
Chiba
Site JP00003
Ehime
Site JP00029
Fukuoka
Site JP00009
Fukushima
Site JP00017
Gifu
Site JP00002
Hiroshima
Site JP00005
Hokkaido
Site JP00024
Hyōgo
Site JP00012
Ibaraki
Site JP00020
Ishikawa
Site JP00026
Kagawa
Site JP00030
Kagoshima
Site JP00014
Kanagawa
Site JP00027
Kochi
Site JP00028
Kumamoto
Site JP00008
Kyoto
Site JP00019
Mie
Site JP00011
Miyagi
Site JP00006
Nagasaki
Site JP00023
Nara
Site JP00013
Niigata
Site JP00010
Numakunai, Iwate
Site JP00025
Okayama
Site JP00022
Osaka
Site JP00016
Saitama
Site JP00018
Shizuoka
Site JP00007
Tokyo
Site JP00021
Wakayama
Site JP00004
Yamagata
About this study
Official title: Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
- Being tested
- Graceptor®
- Keywords
- tacrolimus, cyclosporine, Graceptor®, kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graceptor®Drug
Also called tacrolimus, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ® Receives: Drug: Graceptor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
Measured: 12 months
Secondary outcomes (1)
Renal function, hypertension, hyperlipidaemia, other adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study start15 Nov 2013
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Maintenance Phase After Kidney 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160054
- Sponsor's protocol ID
- GRA006
- Status last verified
- Apr 2019
- First submitted
- 9 Jun 2014
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT02160054
- Acronym / sponsor ID
- GRA006
- Keywords
- tacrolimus, cyclosporine, Graceptor®, kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2013 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 10 Jun 2014 (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.
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Graceptor®patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
Key inclusion criteria (7 listed)
- Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.
- Patients who meet one or more of following criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Graceptor®Also: tacrolimus, FK506oral | Drug | Group 1 |
Primary outcome
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
Time frame: 12 months
1 secondary outcome
Renal function, hypertension, hyperlipidaemia, other adverse events
Time frame: 12 months
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 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Use Central Contact study director
Astellas Pharma Inc
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of the Maintenance Phase After Kidney Transplantation, run by Astellas Pharma Inc at 30 sites in Japan.
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 7 inclusion and 0 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Japan. 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.
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?
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) (time frame: 12 months). 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 21 Oct 2024.