IgA NephropathyPhase 4AIGANCT02981212
Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy
A Phase 4 study testing Mycophenolate Mofetil, ACE inhibitor and Corticosteroid in people with IgA Nephropathy, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Mycophenolate Mofetil, ACE inhibitor and Corticosteroid
- 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
- Jun 2016to Oct 2018
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 19 to 65 years old
- Diagnosed with IgA nephropathy
- Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
- If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2
- ACE inhibitor or ARB for at least 3 months
- Willing and able to provide written informed consent.
Who cannot join
- If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
- Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg
- Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
- serious digestive disorder
- WBC <3000 / mm^3
- Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
Show all 11Show fewer
- Administration of other Investigational drugs within 28days before screening period
- Administration of Investigator drug or other immunosuppressants within 84days before screening period
- Women in pregnant or breast-feeding or don't using adequate contraception.
- Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul
EUNU JUNG, 82-10-5414-7760, oakly74@nate.com
CHANDUK KIM, PhD
About this study
Official title: Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy
The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
Read the detailed description
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.
The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.
The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
- Conditions
- IgA Nephropathy
- Being tested
- Mycophenolate Mofetil, ACE inhibitor, Corticosteroid, ARB
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called MYREPT®
less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
ACE inhibitorDrug
Also called conservative treatment
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
CorticosteroidDrug
Also called prednisolone, methyprednisolone
combination with Mycophenolate Mofetil
ARBDrug
Also called conservative treatment
maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil | Experimental | MYREPT® capsule(CKDpharm, KOREA) and corticosteroid Receives: Drug: Mycophenolate Mofetil; Drug: Corticosteroid |
| Conservative treatment | Active comparator | maintain conservative treatment (ACE inhibitor or ARB) Receives: Drug: ACE inhibitor; Drug: ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate (complete / partial)
Measured: up to 48 weeks
Secondary outcomes (4)
Remission rate (complete / partial)
Measured: at 12 weeks, at 24 weeks, at 36 weeks
eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)
Measured: at 24 weeks, at 36 weeks, at 48 weeks
The incidence of renal replacement therapy
renal replacement therapy; dialysis, new transplant
Measured: up to 48 weeks
The average time to occurrence of renal replacement therapy
renal replacement therapy; dialysis, new transplant
Measured: up to 48 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 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp., Kyung Hee University Hospital at Gangdong, Kyungpook National University Hospital, Pusan National University Yangsan Hospital, Inje University, Seoul St. Mary's Hospital, Chonbuk National University Hospital
- Responsible party
- Principal investigator, Beom Seok Kim, Yonsei University
- Investigators
- BEOMSUK KIM, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981212
- Sponsor's protocol ID
- 062IGA15-1D
- Acronym
- AIGA
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Open Label, Comparative, Phase IV Study to Evaluate the Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid for 48 Weeks in Advanced IgA Nephropathy
- ClinicalTrials.gov ID
- NCT02981212
- Acronym / sponsor ID
- AIGA / 062IGA15-1D
- Conditions
- IgA Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Chong Kun Dang Pharmaceutical Corp., Kyung Hee University Hospital at Gangdong, Kyungpook National University Hospital, Pusan National University Yangsan Hospital, Inje University, Seoul St. Mary's Hospital, Chonbuk National University Hospital
- Study start
- Jun 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 5 Dec 2016 (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 clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
Detailed description
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.
The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.
The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil | Experimental | Drug: Mycophenolate Mofetil, Drug: CorticosteroidMYREPT® capsule(CKDpharm, KOREA) and corticosteroid |
| Conservative treatment | Active comparator | Drug: ACE inhibitor, Drug: ARBmaintain conservative treatment (ACE inhibitor or ARB) |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 19 to 65 years old
- Diagnosed with IgA nephropathy
- Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
- If eGFR (by MDRD) is <50 mL / min / 1.73 m^2, ≥ 15 mL / min / 1.73 m^2
- ACE inhibitor or ARB for at least 3 months
Key exclusion criteria (11 listed)
- If eGFR (by MDRD) is <15 mL / min / 1.73 m^2
- Blood pressure is SBP> 160 mmHg or DBP> 100 mmHg
- Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
- serious digestive disorder
- WBC <3000 / mm^3
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 |
|---|---|---|
| Mycophenolate MofetilAlso: MYREPT®less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally | Drug | Mycophenolate Mofetil |
| ACE inhibitorAlso: conservative treatmentmaintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization | Drug | Conservative treatment |
| CorticosteroidAlso: prednisolone, methyprednisolonecombination with Mycophenolate Mofetil | Drug | Mycophenolate Mofetil |
| ARBAlso: conservative treatmentmaintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization | Drug | Conservative treatment |
Primary outcome
Remission rate (complete / partial)
Time frame: up to 48 weeks
4 secondary outcomes
Remission rate (complete / partial)
Time frame: at 12 weeks, at 24 weeks, at 36 weeks
eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease)
Time frame: at 24 weeks, at 36 weeks, at 48 weeks
The incidence of renal replacement therapy
Time frame: up to 48 weeks
The average time to occurrence of renal replacement therapy
Time frame: up to 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Individual participant dataSharing planned: No
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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.
BEOMSUK KIM principal investigator
Severance Hospital
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 Mycophenolate Mofetil, ACE inhibitor and Corticosteroid in people with IgA Nephropathy, run by Yonsei University 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 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: status not confirmed, as of the sponsor's last update on 5 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EUNJU JUNG (82-10-5414-7760, oakly74@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate (complete / partial) (time frame: up to 48 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 Dec 2016.