Mizoribine for the Treatment of Pediatric IgA Nephropathy

Mizoribine for the Treatment of Pediatric IgA Nephropathy with Moderate Proteinuria--An open, prospective, random, multicenter study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003038

Enrollment

Unknown

Registered

2013-01-11

Start date

2013-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

IgA nephropathy

Interventions

MZR:mizoribine tablet 4 mg/kg a day (not more than 150 mg/d), qd, po + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po

CVT:Lotensin, 0.2 mg/kg a day (not more than 10 mg/d), qd, po + + Dipyridamole, 3 mg/kg a day (not more than 25 mg at a time), tid, po

Eligibility

Sex/Gender

All

Age

6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Understand the whole process of trial, participate in the trial voluntarily and sign informed consent; 2. Age between 6 (include 6)and 18 (include 18) at the selecting day; 3. Be diagnosed as primary IgA nephropathy definitively by renal biopsy; 4. Hematuria and proteinuria or isolated proteinuria as the clinical types; 5. 24 hour urinary protein between 25 mg/kg (include 25 mg/kg) and 50 mg/kg; 6. Do not participate in any drug test in the 3 months before being enrolled in.

Exclusion criteria

Exclusion criteria: 1. Acute nephritis or rapidly progressive glomerulonephritis in clinical types; 2. Ccr<80 ml/min*1.73m2; 3. Secondary IgA nephropathy: for example, purpura nephritis or hepatitis B-related nephritis; 4. With chronic hepatitis (hepatitis B or hepatitis C); 5. With severe gastrointestinal disease: for example, chronic diarrhea or severe peptic ulcer; 6. With WBC<3.0*10^9/L, or anemia (Hb<80 g/L), or PLT<80*10^9/L, or other hematological system diseases; 7. To them, MZR, Lotensin, or dipyridamole can not be administered; 8. To them, powerful immunosuppressive agents (for example, MMF or AZA) are being administered; 9. With hepatic function damage (Transaminases are higher than 1.5 folds of limit); 10. Those (with any other condition) not suitable for enrollment by investigators thoughts.

Design outcomes

Primary

Measure	Time frame
24-hour urinary protein;urinary protein-creatinine ratio;urinary microalbumin-creatinine ratio;	—

Secondary

Measure	Time frame
serum creatinine;BUN;Ccr;NAG;alpha 1-microglobulin;plasma albumin;	—

Countries

China

Contacts

Public ContactDING Jie

djnc_5855@126.com+86 13901368362

Outcome results

None listed

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