Kidney TransplantPhase 4COSMOSNCT02034747
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
A Phase 4 study testing Advagraf and Corticosteroid in people with Kidney Transplant, run by Astellas Pharma Korea, Inc. at 9 sites in South Korea.
Trial summary
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Advagraf and Corticosteroid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 21 Nov 2013to 7 Nov 2015
- 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
- Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
- Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
- The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
- GFR≥30 mL/min
Who cannot join
- Had received an organ transplant other than a kidney
- Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
- Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
- The subject received a kidney transplant from full-HLA identical donor
- Known to have FSGS or MPGN Type II as an underlying disease
- Has elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigated site
- Has liver cirrhosis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Busan
Study site
Chungcheongnam-do
Study site
Daegu
Study site
Gyeonggi-do
Study site
Incheon
Study site
Jeollabuk-do
Study site
Jeollanam-do
Study site
Seoul
Study site
Ulsan
About this study
Official title: A Multicenter, Randomized, Comparison, Open-label, Phase IV Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.
Read the detailed description
The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.
The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.
- Conditions
- Kidney Transplant
- Being tested
- Advagraf, Corticosteroid
- Keywords
- Immunosuppressive regimen, Advagraf, kidney transplant, Corticosteroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
oral
CorticosteroidDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid with the 50% reduced dose | Experimental | oral Receives: Drug: Advagraf; Drug: Corticosteroid |
| Corticosteroid with the maintained dose | Active comparator | oral Receives: Drug: Advagraf; Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the GFR before the treatment (baseline) to that on Week 24
Measured: Baseline and Week 24
Secondary outcomes (5)
Change in the GFR before the treatment (baseline) to that on Week 12
Measured: Baseline and Week 12
Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24
Measured: Baseline, Week 12 and Week 24
Incidence of acute rejection
Measured: Up to Week 24
Safety assessed by the incidence of adverse events, vital signs and Lab-test
Measured: Up to Week 24
Physical examinations including cyclosporine related cosmetic side effect
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study start21 Nov 2013
- Primary completion7 Nov 2015
- Study completion7 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Principal investigator, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034747
- Sponsor's protocol ID
- ADV-KT-13-01
- Acronym
- COSMOS
- Status last verified
- Oct 2024
- First submitted
- 10 Jan 2014
- Last updated
- 1 Nov 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Comparison, Open-label, Phase IV Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02034747
- Acronym / sponsor ID
- COSMOS / ADV-KT-13-01
- Conditions
- Kidney Transplant
- Keywords
- Immunosuppressive regimen, Advagraf, kidney transplant, Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 7 Nov 2015 (actual)
- Study completion
- 7 Nov 2015 (actual)
- First posted
- 13 Jan 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.
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.
Detailed description
The primary objective is to assess the changes in the GFR after 24 weeks of treatment between the group that was reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks and the group with maintained corticosteroid in stable kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen with corticosteroid to an Advagraf®-based immunosuppressive regimen with corticosteroid for kidney transplant subjects whose regimen was converted from a CyA-based immunosuppressive regimen.
The secondary objective is to assess the creatinine clearance rate, acute rejection, satisfaction of medication and safety of the group with a 50% reduced dose of corticosteroid and the group in which the Advagraf ®-based immunosuppressive regimen with maintained corticosteroid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid with the 50% reduced dose | Experimental | Drug: Advagraf, Drug: Corticosteroidoral |
| Corticosteroid with the maintained dose | Active comparator | Drug: Advagraf, Drug: Corticosteroidoral |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Had a kidney transplant at least 12 months before his/her enrollment in this study (including a kidney retransplantation).
- Underwent a CyA-based immunosuppressive regimen since his/her last transplantation. The CyA dose remained unchanged during the last four weeks before the subject's enrollment.
- The immunosuppressive regimen (combination of medications) remained unchanged for a minimum of four weeks before the subject's enrollment.
- GFR≥30 mL/min
Key exclusion criteria (7 listed)
- Had received an organ transplant other than a kidney
- Had an acute rejection episode within 12 weeks before his/her enrollment in this study, or had an acute rejection episode within 24 weeks before his/her enrollment in this study that required anti-lymphocyte antibody therapy
- Had been diagnosed with new-onset malignancy after his/her transplantation, except for basocellular or squamous cell carcinoma of the skin that had been treated successfully
- The subject received a kidney transplant from full-HLA identical donor
- Known to have FSGS or MPGN Type II as an underlying disease
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 |
|---|---|---|
| Advagraforal | Drug | Corticosteroid with the 50% reduced dose, Corticosteroid with the maintained dose |
| Corticosteroidoral | Drug | Corticosteroid with the 50% reduced dose, Corticosteroid with the maintained dose |
Primary outcome
Change in the GFR before the treatment (baseline) to that on Week 24
Time frame: Baseline and Week 24
5 secondary outcomes
Change in the GFR before the treatment (baseline) to that on Week 12
Time frame: Baseline and Week 12
Change in the creatinine clearance before the treatment (baseline) to those on Weeks 12 and 24
Time frame: Baseline, Week 12 and Week 24
Incidence of acute rejection
Time frame: Up to Week 24
Safety assessed by the incidence of adverse events, vital signs and Lab-test
Time frame: Up to Week 24
Physical examinations including cyclosporine related cosmetic side effect
Time frame: Up to Week 24
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 1 Nov 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.
Medical Director principal investigator
Astellas Pharma Inc
9 sites 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 Corticosteroid in people with Kidney Transplant, run by Astellas Pharma Korea, Inc. at 9 sites 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 4 inclusion and 7 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 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Change in the GFR before the treatment (baseline) to that on Week 24 (time frame: Baseline and Week 24). 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 1 Nov 2024.