A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
Actual Study Start Date: September 9, 2021
Estimated Primary Completion Date: February 29, 2024
Estimated Study Completion Date: May 31, 2024
Arm:
- Experimental: HR19042 Capsules
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 210 |
| Actual Study start date | 09 September 2021 |
| Estimated Study Completion Date | 31 May 2024 |