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

Primary Purpose

IgA Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR19042 Capsules
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NanFang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HR19042 Capsules

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in urine protein creatinine ratio (UPCR)

Secondary Outcome Measures

Change from baseline in 24-hour proteinuria
Change from baseline in urine albumin creatinine ratio (UACR)
Change from baseline in estimated GFR
Change from baseline in estimated GFR

Full Information

First Posted
August 17, 2021
Last Updated
October 11, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05016323
Brief Title
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR19042 Capsules
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HR19042 Capsules
Intervention Description
HR19042 Capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in urine protein creatinine ratio (UPCR)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change from baseline in 24-hour proteinuria
Time Frame
9 months
Title
Change from baseline in urine albumin creatinine ratio (UACR)
Time Frame
9 months
Title
Change from baseline in estimated GFR
Time Frame
9 months
Title
Change from baseline in estimated GFR
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or male patients ≥18 years old； Biopsy-confirmed primary IgA nephropathy； Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g； Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2； Willing and able to take adequate contraception during the trial; Willing and able to give informed consent and follow the protocols during the trial. Exclusion Criteria: Systemic diseases which could lead to secondary IgA nephropathy； Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days； Patients with severe cardiovascular diseases； Patients diagnosed with malignancy within the past 5 years； Patients with liver cirrhosis； Patients received organ transplantation； Patients with uncontrolled Type 1 or 2 diabetes； Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests； Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening； Patients treated with any systemic corticosteroids within the past 3 months before screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, M.D
Phone
+0518-81220121
Email
yong.cao@hengrui.com
Facility Information:
Facility Name
NanFang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanfan Hou, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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