A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-09

Study Completion Date

2025-11-30

Brief Summary

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This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.

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Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HR19042 Capsules

Group Type EXPERIMENTAL

HR19042 Capsules

Intervention Type DRUG

HR19042 Capsules

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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HR19042 Capsules

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Female or male patients ≥18 years old；
2. Biopsy-confirmed primary IgA nephropathy；
3. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
4. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
5. Willing and able to take adequate contraception during the trial;
6. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria

1. Systemic diseases which could lead to secondary IgA nephropathy；
2. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
3. Patients with severe cardiovascular diseases；
4. Patients diagnosed with malignancy within the past 5 years；
5. Patients with liver cirrhosis；
6. Patients received organ transplantation；
7. Patients with uncontrolled Type 1 or 2 diabetes；
8. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
9. Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
10. Patients treated with any systemic corticosteroids within the past 3 months before screening.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No