Efficacy of Mizoribine for Children with Henoch-Schnlein Purpura Nephritis Presenting with Nephrotic Range Proteinuria: A Prospective and Controlled Study in China

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPC-16008619
• Date of registration: 2016-06-09
• Prospective Registration: Yes
• Primary sponsor: Nanjing General Hospital of Nanjing Military Command
• Public title: Efficacy of Mizoribine for Children with Henoch-Schnlein Purpura Nephritis Presenting with Nephrotic Range Proteinuria: A Prospective and Controlled Study in China
• Scientific title: Efficacy of Mizoribine for Children with Henoch-Schnlein Purpura Nephritis Presenting with Nephrotic Range Proteinuria: A Prospective and Controlled Study in China
• Date of first enrolment: 2016-07-01
• Target sample size: mizoribine:180;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=14595
• Study type: Interventional study
• Study design: Cross-sectional
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Zhengkun Xia
• Affiliation: Nanjing General Hospital of Nanjing Military Command

• Name: Zhengkun Xia
• Affiliation: Nanjing General Hospital of Nanjing Military Command

Key inclusion & exclusion criteria

Inclusion criteria: 1. HSPN patients with moderate proteinuria (grade IIb and IIIa)(2550mg/kg/d/24 h proteinuria);
2. HSPN patients with nephrotic syndrome (grade?b and ?) (>50mg/kg/d/24 h proteinuria);
3. Male or female patient between 5 and 18 years age;
4. Patient who have participated any drug study within 3 months prior to screening;
5. Patients who sign the informed consent form.
Exclusion criteria: 1. HSPN patients with grade IV or V disease;
2. Patient with IgA nephritis, thrombocytopenia purpura and systemic lupus erythematosus;
3. Patient with Ccr > 30 umol/L;
4. Patient who had history of allergy to MZR;
5. Patient with white blood cell count <3×10^3/mm3;
6. Patients with severe complications of liver, kidney and hematopoietic system;
7. When serum uric acid have > 420 mol/L, and if patient who have received the treatment of allopurinol (daily 8mg/kg, 2-3 times a day) for 2 weeks, patient who can not be reduced to < 420 mmol/L;
8. Patient who had received immunosuppressant (Cyclophosphamide, Tripterygium wilfordii (Chinese traditional medicine), Mycophenolate mofetil, Azathioprine and Tacrolimus, etc.) with immunosuppressive effect within 2 weeks prior to screening;
9. Patient who is unsuitable for participating in this study in the opinion of investigators.

Age minimum: 5
Age maximum: 18
Gender: Both

Health Condition(s) or Problem(s) studied

Children with Henoch-Sch?nlein Purpura Nephritis

Intervention(s)

mizoribine:5 mg/kg body weight daily (maximum total dose: 150 mg);

Primary Outcome(s)

Total Remission Rate = Complete remission rate+Partial remission rate;Total Remission Rate;Partial remission rate;

Secondary Outcome(s)

reducing effect of proteinuria;reducing effect of steroid;Assessment of the changes and percentage change of Serum albumin, serum creatinine, eGFR, Cholesterol, triglyceride, hematuria, ß-N-acetylglucosaminidase, C reactive protein and uric acid from the baseline;

Source(s) of Monetary Support

self-financing