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

October 11, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Fanfan Hou, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: HR19042 Capsules
Drug: HR19042 Capsules
HR19042 Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in urine protein creatinine ratio (UPCR)
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in estimated GFR
Time Frame: 9 months
9 months
Change from baseline in 24-hour proteinuria
Time Frame: 9 months
9 months
Change from baseline in urine albumin creatinine ratio (UACR)
Time Frame: 9 months
9 months
Change from baseline in estimated GFR
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2021

Primary Completion (Anticipated)

February 29, 2024

Study Completion (Anticipated)

May 31, 2024

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR19042-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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