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Real-World Study Protocol for Huangkui Capsule in IgA Nephropathy: The IgA Nephropathy Registry Study

Real-World Study Protocol for Huangkui Capsule in IgA Nephropathy: The IgA Nephropathy Registry Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002029
Enrollment
Unknown
Registered
2025-10-28
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunoglobulin A Nephropathy

Interventions

Treatment Group:Huangkui Capsule
Control Group:Not receiving Huangkui Capsule, including those on other therapies

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with primary IgA nephropathy. 2.Aged 18 to 75 years, regardless of gender. 3.24-hour urinary protein excretion > 0.3 g. 4.eGFR = 30 mL/min/1.73m² (calculated by CKD-EPI equation). 5.Patients provided informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1.Patients with any form of secondary IgA nephropathy. 2.Renal biopsy findings consistent with diabetic nephropathy and/or presence of diabetic microvascular complications. 3.Individuals who are lactating, pregnant, or planning pregnancy during the study period. 4.Patients with severe cardiovascular, cerebrovascular, hepatic, hematologic, or other serious diseases that may impact survival. 5.Current participation in another clinical trial.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein;

Secondary

MeasureTime frame
Changes in TCM Syndrome Score;estimated glomerular filtration rate;serum creatinine;blood urea nitrogen;uric acid;serum cystatin C;high-sensitivity C-reactive protein;urinary red blood cell count;Complete Renal Response;

Countries

China

Contacts

Public ContactBo Yang

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

yb8203@126.com18622100192

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026