Status:
ACTIVE_NOT_RECRUITING
Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborating Sponsors:
China Academy of Chinese Medical Sciences
Conditions:
IgA Nephropathy at High Risk of Developing ESRD
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal p...
Detailed Description
The investigators plan to randomize 60 participants with biopsy-proven IgAN to a YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression...
Eligibility Criteria
Inclusion
- patients who maintain regular follow-ups at Guang'anmen Hospital, agree to participate, and provide informed consent;
- biopsy-proven IgA nephropathy, with recent progression to high-risk IgAN\*;
- 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
- secondary IgAN;
- comorbidity of other primary or secondary glomerular diseases;
- comorbidity of severe primary diseases such as cardiovascular, hepatic, cerebral, and hematopoietic system diseases or mental disorders;
- allergy or intolerance to the experimental medication (e.g., RAS blockers, prednisolone, cyclophosphamide, YQF compound and its placebo compound);
- contraindications to immunosuppression therapy-acute and chronic infectious diseases, malignancies, leukopenia, thrombocytopenia, gastrointestinal hemorrhage, ulcers of stomach or duodenum, post-transplantation;
- pregnant or lactating women;
- unwilling to participate in this study, failure to accept or tolerate Chinese medicine compound;
- history of alcohol or drug abuse;
- poor compliance, loss to follow-up;
- participation in another clinical investigation.
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03418779
Start Date
July 4 2019
End Date
December 31 2024
Last Update
September 25 2024
Active Locations (1)
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1
Guang anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100053