Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-11001454
• Date of registration: 2011-08-08
• Prospective Registration: No
• Primary sponsor: Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University
• Public title: Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial
• Scientific title: Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial
• Date of first enrolment: 2011-08-01
• Target sample size: Group A:60;Group B:60;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8085
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Nan Xu
• Affiliation: Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University

• Name: Jianghua Chen

Key inclusion & exclusion criteria

Inclusion criteria: 1. Willing and able to give informed consent;
2. Male or female patients, ageing 18-65yr;
3. Newly onset nephritic syndrome( urine protein>3.5 g/d, serum albumin<30 g/L);
4. Renal biopsy-verified minimal change disease (diagnose criteria: appendix 1);
5. Urine volume>600mL/d, or>1000mL/d after using diuretic drugs;
6. Serum creatinine (SCr)<=133mmol/L;
7. Female patients in child-bearing periond have negative urine pregnancy test,and willing to use adequate contraception.
Exclusion criteria: Patents will be excluded if andy of the following criteria is present:
1. No informed consent, or unable or unwilling to meet the requirements of the protocol;
2. Secondary minimal change disease(malignance, drugs, etc)
3. Patients previously treated with steroid or other immunosuppressent (cyclophosphamide, cyclosporin, mycophe nolat mofetil);
4. Patients diagnosed with diabetes (defined as FBS >=7.0 mmol/L or diabetes symptoms + RBS >=11.1 mmol/L or 2h PBS>=11.1 mmol/L) or impaired glucose tolerance (2h PBS 7.8–11 mmol/L);
5. Patients known to be allergic to tacrolimus, prednisone, or any intergrant of these drugs;
6. Patients with HBV serum indicators positive (HbsAg or/and HbeAg or/and HbcAb), HCV positive or liver dysfunction (ALT/AST or Bil above twice the normal value, last more than 2weeks);
7. Patients with history of pancreatitis or gastrointestinal ulcer and/or gastrointestinal bleesing during last 6 monthes;
8. Patients with history of congenital or acquired immunodeficiency, or combined with active tuberculosis/active CMV infections;
9. Patients with other sever physical or mental diseases;
10. Patients with history of maliganacy during last 5 years;
11. Patients with history of congenital heart diseases, heart failure, arhythmia or other severe cardiovascular diseases;
12. Patients with history of sever infections in need of introvenous antibiotics;
13. Female patients: pregnant or breast feeding or unwilling to take adequate contraception during the study;
14. Patients participated in other clinicl trials during last 3 months;
15. Other medical or social reasons for exclusion at the discretion of the investigators.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

minimal change disease in adults

ICD10:N04.001

Intervention(s)

Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape;

Primary Outcome(s)

remission rates in 12w and the end of study;

Secondary Outcome(s)

weight and BMI;new-onset diabetes or abnormal glucose tolerance;Osteoporosis;Spiritual and psychological abnormalities;infection;morbidty of acute renal failure;life style quality changes;Renal biopsy pathological changes before and after treatment;Extra hospitalizations;time to achieve complete and partial remission;the proportion of patients with ineffective therap;recurrence;changes of kidney function;Centripetal obesity index;changes of kidney function;

Source(s) of Monetary Support

Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University