Effect of Immunosuppression in IgA nephropathy

Not Applicable

Recruiting

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0003039
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

1) Biopsy-proven IgA nephropathy
2) Urinary protein excretion above the target of 1.0 g per day despite the dose of renin–angiotensin system blocker is
increased to the maximum approved daily dose
3) Blood pressure lower than 130/80 mmHg after administration of renin–angiotensin system blocker,
and other kinds of anti-hypertensive medications if needed
4) eGFR =30 ml per minute per 1.73 m2
5) Age =19-years old

Exclusion Criteria

1)Candidate for immunosuppressive therapy
?Minimal change disease with IgA nephropathy
?Crescents= 25% in biopsy findings
2)Contraindication for immunosuppressive therapy
?Active pulmonary tuberculosis
?Diagnosed with cancer in the last 5 years
?Planning for pregnancy or breastfeeding
?Acute hepatitis, chronic hepatitis, liver cirrhosis, HIV infection
?Gastrointestinal bleeding within 2 weeks
?Need for maintenance of immunosuppressive therapy for other reasons (e.g., transplant patients, inflammatory bowel diseases that require steroid treatment)
3)Recent immunosuppressive therapy within the past year
Patients with less than 10mg of steroid can can be enrolled after 3 months of discontinuation
4)Uncontrolled hypertension (BP=160/100 mmHg)
5)Diabetes mellitus (fasting blood glucose=126 mg/dL, or HbA1c=6.5%, or the use of antidiabetic medications)
6)Age<19-years old
7)Secondary IgA nephropathy: lupus nephritis, liver cirrhosis, Henoch-Sholein purpura
8)Patients who participated in other clinical trials within the last 3 months

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite of a = 30% decline in eGFR or the onset of end-stage renal disease which is defined as initiation of dialysis or receipt of a transplant.

Secondary Outcome Measures

Name	Time	Method
Complete remission rate of proteinuria (UPCR <0.2 g/g creatinine) ,Partial remission rate of proteinuria (0.2 = UPCR < 1 g/g creatinine and = 50% reduction from baseline),