Mizoribine for the Treatment of Pediatric IgA Nephropathy

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-13003038
• Date of registration: 2013-01-11
• Prospective Registration: No
• Primary sponsor: Peking University First Hospital
• Public title: Mizoribine for the Treatment of Pediatric IgA Nephropathy
• Scientific title: Mizoribine for the Treatment of Pediatric IgA Nephropathy with Moderate Proteinuria--An open, prospective, random, multicenter study
• Date of first enrolment: 2013-01-01
• Target sample size: MZR:60;CVT:60;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=6519
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: DING Jie

• Name: WANG Shuhan
• Affiliation: Ningbo Lonrain Meditech. Ltd.

Key inclusion & exclusion 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: 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.

Age minimum: 6
Age maximum: 18
Gender: Both

Health Condition(s) or Problem(s) studied

IgA nephropathy

Intervention(s)

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;

Primary Outcome(s)

24-hour urinary protein;urinary protein-creatinine ratio;urinary microalbumin-creatinine ratio;

Secondary Outcome(s)

serum creatinine;BUN;Ccr;NAG;alpha 1-microglobulin;plasma albumin;

Source(s) of Monetary Support

Ningbo Lonrain Meditech. Ltd.