Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-IPR-15006760
• Date of registration: 2015-07-16
• Prospective Registration: Yes
• Primary sponsor: Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University
• Public title: Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study
• Scientific title: Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study
• Date of first enrolment: 2015-08-07
• Target sample size: Tacrolimus Group :90;Glucocorticoids Group :90;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11448
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

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

• Name: Chen Jianghua

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients are aged 18-65 years, the gender is not limited, willing to sign the informed consent;
2) Screening primary IgAN patients with renal biopsy in 3 years(patient required a written pathology report);
3) 24 hour urinary protein quantitation: more than 1.0g/24h, and less than 3.5g/24h;
4) glomerular filtration rate (eGFR) >= 45ml/min/1.73m2 (2009EPI);
5) The pregnancy test results of women of childbearing age were negative, and they should agree to take contraceptive measures.
Exclusion criteria: 1) Renal pathology showed: crescent glomerulonephritis (the ratio of crescent >50%); or / and interstitial fibrosis >50%;
2) Active hepatitis B (including HBsAg, HBeAg, and HBcAb test positive or HBsAg, HBeAb, and HBcAb test positive ) or serum markers (HBsAg and/or HBeAg or/and HBcAb) positive, hepatitis C and tuberculosis, cytomegalovirus, serious fungal infections or HIV infection;
3) Active peptic ulcer before randomization within 3 months;
4) Malignant tumor;
5) Diabetes mellitus (DM) (diabetes mellitus diagnosis standard, exincluding impaired glucose tolerance and impaired fasting glucose regulation;
6) Obesity, body mass index (BMI) >28;
7) Abuse of drugs or alcohol;
8) Serious cardiovascular and cerebrovascular diseases, such as myocardial infarction; cerebral infarction, cerebral hemorrhage, coronary heart disease, myocarditis, arrhythmia etc.;
9) Chronic obstructive pulmonary disease, or asthma that need oral corticosteroid therapy;
10) used prednisone, MMF, tacrolimus, CsA, azathioprine and other drug treatment Within 3 months of screening, and the course of treatment was more than 4 weeks. Or used cyclophosphamide (cumulative dose >1.0g), methylprednisolone pulse therapy;
11) ALT, AST or total bilirubin exceeded 1.1 times more than the normal limit;
12) Secondary IgAN, such as allergic purpura, system lupus erythematosus, cirrhosis of the liver, virus hepatitis, portal hypertension, rheumatoid arthritis, ankylosing spondylitis, sjogren syndrome, scleroderma, Reiter's syndrome, Behcet's disease, Crohn's disease, ulcer colitis, psoriasis, HIV infection;
13) Malignant or difficult-controlled hypertension (systolic blood pressure >160mmHg; diastolic blood pressure >110mmHg);
14) Being or planning to become pregnant or nursing;
15) Allergy with test drugs or related products;
16) Participation in other clinical studies in the first 3 months ;
17) Patients who competent doctors believe could not comply with the program.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

IgA nephropathy

Intervention(s)

Tacrolimus Group :Tacrolimus;Glucocorticoids Group :Glucocorticoids;

Primary Outcome(s)

24 hour urinary protein quantitation;

Secondary Outcome(s)

Serum creatinine;Glomerular filtration rate;Liver function;Routine blood test;Routine urine test;

Source(s) of Monetary Support

Scientific research fund