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

IgA Nephropathy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016323
• Other study ID #: HR19042-201
• Status: Recruiting
• Phase: Phase 2
• Start date: September 9, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yong Cao, M.D
• Phone: +0518-81220121
• Email: yong.cao[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: May 31, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• HR19042 Capsules
HR19042 Capsules
• Placebo
Placebo

Locations

Country	Name	City	State
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in urine protein creatinine ratio (UPCR)		9 months
Secondary	Change from baseline in 24-hour proteinuria		9 months
Secondary	Change from baseline in urine albumin creatinine ratio (UACR)		9 months
Secondary	Change from baseline in estimated GFR		9 months
Secondary	Change from baseline in estimated GFR		12 months