MCNSPhase 4T-OPTIMUMNCT01763580
A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome
A Phase 4 study testing Tacrolimus and Prednisolone in people with MCNS and Minimal Change Nephrotic Syndrome (MCNS), run by Astellas Pharma Korea, Inc. at 1 site in South Korea.
Trial summary
To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 16 to 78 years
- Conditions the study is for
- MCNS, Minimal Change Nephrotic Syndrome (MCNS)
- What is being tested?
- Tacrolimus and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jul 2012to 21 Aug 2017
- 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 16 to 78 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who have been diagnosed with initial or relapsed primary minimal-change nephrotic syndrome
- patients whose urine protein-creatinine ratio (UPCR) is more than 3.0
Who cannot join
- patients whose eGFR is less than 30 ml/min/1.73 m2
- patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil, or rituximab, within two weeks before the study
- patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before the study
- patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or who cannot or do not want to use any contraceptive method
- patients who are hypersensitive to the investigational drug or to macrolide, such as azithromycin, clarithromycin, or roxithromycin
- patients who were treated with a live vaccine within four weeks before the study
Show all 11Show fewer
- patients whose liver panel laboratory test result is three times the normal range, or acute hepatitis patients whose serum bilirubin has been clinically significantly higher than 3.6 mg/dL for more than 1 month
- patients who have a significant general disease that makes it inappropriate for them to participate in this study as adjudged by the investigator (e.g., cardiovascular-acute myocardial infarction, heart failure [classified as more than New York Heart Association {NYHA} class III], hepatic/gastrointestinal/neurologic disease, blood disorder, cancer, infection, renal disorder other than minimal-change nephrotic syndrome, rheumatic arthritis with pneumonia interstitials)
- patients who have genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
- patients to whom another investigational drug was administered within 30 days from the enrollment in the study
- patients who participated in the past phases of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)
To compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.
- Conditions
- MCNS, Minimal Change Nephrotic Syndrome (MCNS)
- Being tested
- Tacrolimus, Prednisolone
- Keywords
- Glomerulonephritis, Tacrolimus, Nephrotic syndrome
- Medical subject headings
- Nephrosis, Lipoid, Glomerulonephritis, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called FK506, Prograf Capsule
Oral
PrednisoloneDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus with low-dose corticosteroid | Experimental | Oral Receives: Drug: Tacrolimus; Drug: Prednisolone |
| High-dose corticosteroid alone | Active comparator | Oral Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
Measured: up to 8 weeks after treatment
Secondary outcomes (4)
The period until the UPCR is decreased below 0.2
Measured: up to 8 weeks after treatment
The percentage of subjects who show relapse after the remission
Measured: up to 24 weeks
The period until the relapse happens from the complete remission
Measured: up to 24 weeks
Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study start16 Jul 2012
- Primary completion2 May 2017
- Study completion21 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MCNSStudies 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
- 144 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
- NCT01763580
- Sponsor's protocol ID
- PRGNS-11-02-KOR
- Acronym
- T-OPTIMUM
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2012
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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/.
Publications
Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
PubMed 35230699
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS)
- ClinicalTrials.gov ID
- NCT01763580
- Acronym / sponsor ID
- T-OPTIMUM / PRGNS-11-02-KOR
- Conditions
- MCNS, Minimal Change Nephrotic Syndrome (MCNS)
- Keywords
- Glomerulonephritis, Tacrolimus, Nephrotic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 21 Aug 2017 (actual)
- First posted
- 9 Jan 2013 (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 compare the therapeutic effect of tacrolimus in combination with low-dose corticosteroid with high-dose corticosteroid alone in patients with minimal-change nephrotic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus with low-dose corticosteroid | Experimental | Drug: Tacrolimus, Drug: PrednisoloneOral |
| High-dose corticosteroid alone | Active comparator | Drug: PrednisoloneOral |
Who may qualify
- Ages
- 16 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients who have been diagnosed with initial or relapsed primary minimal-change nephrotic syndrome
- patients whose urine protein-creatinine ratio (UPCR) is more than 3.0
Key exclusion criteria (11 listed)
- patients whose eGFR is less than 30 ml/min/1.73 m2
- patients who were treated with immunosuppressants, such as tacrolimus, cyclosporine, cyclophosphamide (Cytoxan), mizoribine (Bredinin), levamisole, azathioprine, mycophenolate mofetil, or rituximab, within two weeks before the study
- patients to whom more than 10 mg prednisolone or an equivalent dose of steroid was administered daily within two weeks before the study
- patients who are pregnant, breastfeeding, or planning to be pregnant or to breastfeed within six months after the study completion, or who cannot or do not want to use any contraceptive method
- patients who are hypersensitive to the investigational drug or to macrolide, such as azithromycin, clarithromycin, or roxithromycin
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 |
|---|---|---|
| TacrolimusAlso: FK506, Prograf CapsuleOral | Drug | Tacrolimus with low-dose corticosteroid |
| PrednisoloneOral | Drug | High-dose corticosteroid alone, Tacrolimus with low-dose corticosteroid |
Primary outcome
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2
Time frame: up to 8 weeks after treatment
4 secondary outcomes
The period until the UPCR is decreased below 0.2
Time frame: up to 8 weeks after treatment
The percentage of subjects who show relapse after the remission
Time frame: up to 24 weeks
The period until the relapse happens from the complete remission
Time frame: up to 24 weeks
Safety assessed by the incidence of adverse events, labo-tests, vital signs, ECGs and chest X-rays
Time frame: up to 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 31 Oct 2024.
- Derived from this study: PubMed 35230699Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
- 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/.
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 Tacrolimus and Prednisolone in people with MCNS and Minimal Change Nephrotic Syndrome (MCNS), 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 2 inclusion and 11 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 31 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 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?
The percentage of subjects who show a decreased UPCR (Urine Protein Creatinine Rate) of less than 0.2 (time frame: up to 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763580, which also lists 1 linked publication.
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 31 Oct 2024.