Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWuhan Createrna Science and Technology Co., Ltd

About this trial

Efficacy and safety of MY008211A in IgAN patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MY008211A tablets

    Drug

    MY008211A BID

  • MY008211A tablets matched placebo

    Drug

    Matching placebo to MY008211A taken twice a day.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: MY008211A 200 mg BIDExperimental treatment 1 intervention
Group B: MY008211A 400 mg BIDExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 12

Secondary outcomes

1

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.

Time frame
up to 24 weeks
2

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.

Time frame
up to 24 weeks
3

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.

Time frame
up to 24 weeks
4

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.

Time frame
up to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: