Health TrialsbyHealthPanel

A Trial of HRS-5965 Capsule in Primary IgA Nephropathy

ConditionPrimary IgA Nephropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.

About this trial

This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent；

Weight ≥35 kg, Body mass index (BMI) < 37.5kg /m2;

Primary IgA nephropathy was confirmed by renal biopsy within 8 years;

24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;

Disqualifiers

Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;

Patients with secondary IgA nephropathy as determined by the investigator;

IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;

Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-5965

    Drug

    HRS-5965

  • Placebo

    Drug

    Placebo

Treatment groups

378 Participants
are divided into 2 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline

Time frame
Baseline and Week 36
2

The total annualized slope of estimated glomerular filtration rate（eGFR）

Time frame
Baseline and Week 104

Secondary outcomes

1

The total annualized slope of estimated glomerular filtration rate（eGFR）

Time frame
up to Week 36
2

Proportion of subjects with 24-hour urinary protein excretion (24-UPE) < 0.5 g/d and < 0.3 g/d

Time frame
up to Week 36 and Week104
3

Proportion of subjects with 24-UPCR declined >50% to baseline

Time frame
up to Week 36 and Week104
4

Ratio of 24-hour Urinary protein to creatinine ratio (24-UPCR) to baseline

Time frame
up to Week 36 and Week104

Other outcomes

Sponsors and contacts

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

Chengdu Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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