Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT03418779
• Date of registration: 11/01/2018
• Prospective Registration: Yes
• Primary sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Public title: Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD TCMWINE
• Scientific title: Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)
• Date of first enrolment: July 4, 2019
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03418779
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Jie Wang
• Affiliation: Guang anmen Hospital, China Academy of Chinese Medical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

1. patients who maintain regular follow-ups at Guang'anmen Hospital, agree to
participate, and provide informed consent;

2. biopsy-proven IgA nephropathy, with recent progression to high-risk IgAN*;

3. eGFR 15 to 60 ml/min/1.73 m2, calculated with the use of CKD-EPI Creatinine Equation
2009.

- High-risk IgAN: persistent proteinuria = 1 g/d despite at least 8 weeks of
optimal supportive care [maximally tolerated RAS blocker which refers to no
symptomatic hypotension, no hyperkalemia, and serum creatinine increased by not
more than 30% of baseline, blood pressure control meeting targets (135/85 mmHg or
lower), and dietary management (sodium intake less than 6 g/d, protein intake of
0.6-0.8 g/kg/day, and low-fat diet)], the mean annual eGFR decline rate
(eGFR-slope) >10 ml/min per 1.73 m2 per year, while needing to restart
immunosuppressive therapy; or eGFR<60 ml/min/1.73 m2 at the first diagnosis.

Exclusion Criteria:

1. secondary IgAN;

2. comorbidity of other primary or secondary glomerular diseases;

3. comorbidity of severe primary diseases such as cardiovascular, hepatic, cerebral, and
hematopoietic system diseases or mental disorders;

4. allergy or intolerance to the experimental medication (e.g., RAS blockers,
prednisolone, cyclophosphamide, YQF compound and its placebo compound);

5. contraindications to immunosuppression therapy-acute and chronic infectious diseases,
malignancies, leukopenia, thrombocytopenia, gastrointestinal hemorrhage, ulcers of
stomach or duodenum, post-transplantation;

6. pregnant or lactating women;

7. unwilling to participate in this study, failure to accept or tolerate Chinese medicine
compound;

8. history of alcohol or drug abuse;

9. poor compliance, loss to follow-up;

10. participation in another clinical investigation.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy at High Risk of Developing ESRD

Intervention(s)

Other: Yi-Qi-Qing-Jie herbal compound placebo

Drug: Immunosuppressants

Drug: The Yi-Qi-Qing-Jie herbal compound

Other: Optimized Supportive Care

Primary Outcome(s)

First occurrence of 40% decrease in eGFR from baseline [Time Frame: Baseline, until the first occurrence or 3 years]

First occurrence of progression to continuous renal replacement [Time Frame: Until occurrence or 3 years]

Death due to renal disease [Time Frame: Until occurrence or 3 years]

Secondary Outcome(s)

The remission rate of symptoms and inflammation status [Time Frame: Week 48]

Mean annual reduction in eGFR based on SCr [Time Frame: 48 weeks]

Proteinuria remission [Time Frame: Week 24, 36, and 48 in the treatment period, and month 6, 12, 24, or 36 if possible]

Secondary ID(s)

TCMWINE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

China Academy of Chinese Medical Sciences