IgA Nephropathy (IgAN)Phase 2NCT06687174
Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
A Phase 2 study testing MY008211A tablets in people with IgA Nephropathy (IgAN), run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial summary
Efficacy and safety of MY008211A in IgAN patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- MY008211A tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 and ≤ 75 years of age at Screening.
- Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
- Subjects with a biopsy-confirmed diagnosis of IgAN.
- Urine protein ≥0.75 g/24h from a 24h urine collection.
- All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
- Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
- Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
- Vaccination for the prevention of S. pneumoniae is required within 5 years.
Who cannot join
- Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
- Presence of any secondary IgAN.
- Presence of rapidly progressive glomerulonephritis.
- Presence of other chronic kidney diseases.
- Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
- A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
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- Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
- Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
- Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
- Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
- Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hong Zhang, PH.D., (+86)-010-83572388, hongzh@bjmu.edu.cn
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
Efficacy and safety of MY008211A in IgAN patients
Read the detailed description
This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- MY008211A tablets, MY008211A tablets matched placebo
- Keywords
- kidney disease, Primary glomerular disease
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MY008211A tabletsDrug
MY008211A BID
MY008211A tablets matched placeboDrug
Matching placebo to MY008211A taken twice a day.
| Study group | Role | What they receive |
|---|---|---|
| MY008211A 200 mg BID | Experimental | 200 mg taken twice a day. Receives: Drug: MY008211A tablets |
| MY008211A 400 mg BID | Experimental | 400 mg taken twice a day. Receives: Drug: MY008211A tablets |
| Placebo | Placebo comparator | Matching placebo to MY008211A taken twice a day. Receives: Drug: MY008211A tablets matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
Participants collected their urine over a 24-hour period.
Measured: Week 12
Secondary outcomes (6)
The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.
Participants collected their urine over a 24-hour period.
Measured: up to 24 weeks
The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Measured: up to 24 weeks
The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Measured: up to 24 weeks
The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.
Participants collected all of their urine over a 24-hour period.
Measured: up to 24 weeks
Change from baseline in serum creatinine at each visit during treatment period.
Serum creatinine
Measured: up to 24 weeks
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.
eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
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 posted13 Nov 2024
- Study start31 Dec 2024 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hong Zhang, PH.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687174
- Sponsor's protocol ID
- MY008211A-IgAN-2-01
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
- ClinicalTrials.gov ID
- NCT06687174
- Acronym / sponsor ID
- MY008211A-IgAN-2-01
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- kidney disease, Primary glomerular disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Nov 2024 (actual)
- 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.
Efficacy and safety of MY008211A in IgAN patients
Detailed description
This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MY008211A 200 mg BID | Experimental | Drug: MY008211A tablets200 mg taken twice a day. |
| MY008211A 400 mg BID | Experimental | Drug: MY008211A tablets400 mg taken twice a day. |
| Placebo | Placebo comparator | Drug: MY008211A tablets matched placeboMatching placebo to MY008211A taken twice a day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females ≥ 18 and ≤ 75 years of age at Screening.
- Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
- Subjects with a biopsy-confirmed diagnosis of IgAN.
- Urine protein ≥0.75 g/24h from a 24h urine collection.
- All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
Key exclusion criteria (11 listed)
- Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
- Presence of any secondary IgAN.
- Presence of rapidly progressive glomerulonephritis.
- Presence of other chronic kidney diseases.
- Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
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 |
|---|---|---|
| MY008211A tabletsMY008211A BID | Drug | MY008211A 200 mg BID, MY008211A 400 mg BID |
| MY008211A tablets matched placeboMatching placebo to MY008211A taken twice a day. | Drug | Placebo |
Primary outcome
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
Time frame: Week 12
Participants collected their urine over a 24-hour period.
6 secondary outcomes
The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.
Time frame: up to 24 weeks
The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.
Time frame: up to 24 weeks
The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.
Time frame: up to 24 weeks
The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.
Time frame: up to 24 weeks
Change from baseline in serum creatinine at each visit during treatment period.
Time frame: up to 24 weeks
Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
Hong Zhang, PH.D. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MY008211A tablets in people with IgA Nephropathy (IgAN), run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
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 8 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: opening soon, as of the sponsor's last update on 18 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 1 site in China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donghui Li, PH.D. ((+86)027-68788900, lidonghui@createrna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12. (time frame: Week 12). 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 18 Nov 2024.