None listed
Conditions
Brief summary
Remission of hematuria and proteinuria is a strong predictor of stable renal function in IgA nephropathy. Steroid pulse therapy combined with tonsilectomy can achieve relatively higher remission rate of hematuria and proteinuria in IgA nephropathy. Some of the patients can maintain the remission even after discontinuation of drug therapy. Drug-free remission may be critical for patients, especially younger women. We conduct the study to evaluate the effectiveness of Candesartan combined with steroid pulse therapy and tonsillectomy on clinical remission in IgA nephropathy. Additionally, we evaluate the efficacy of Candesartan, the dose of which is increased regardless of blood pressure, on the remission rate in the patients, who do not achieve the remission by the combination steroid pulse therapy and tonsilectomy .
Interventions
Candesartan, which is added on the control treatment (steroid pulse therapy, tonsillectomy and antiplatelets )
Candesartan and steroid pulse therapy administered simultaneously from baseline to 6 months, tonsilectomy done between 1-6 months, and candesartan restarted if necessary from 12-24 months.
1. Candesartan: it is started with the dose of 2-8mg oral tablet once daily and increased the dose up to 12 mg once daily if patients did not achieve remission of proteinuria for 6 months. The dose pr
Candesartan, which is added on the control treatment (steroid pulse therapy, tonsillectomy and antiplatelets ) Candesartan and steroid pulse therapy administered simultaneously from baseline to 6 months, tonsilectomy done between 1-6 months, and candesartan restarted if necessary from 12-24 months. 1. Candesartan: it is started with the dose of 2-8mg oral tablet once daily and increased the dose up to 12 mg once daily if patients did not achieve remission of proteinuria for 6 months. The dose prescribed at discretion of treating clinician based on individual patient characteristics. 2. steroid pulse therapy: a) methyl prednisolone 500 mg/d b) intravenousy administered for serial 3 days followed by oral prednisolone (PSL) 30 mg/d for subsequent 4 days. c) three courses for initial serial 3 weeks followed by oral PSL 30 mg once alternative day for next 2 months. The dose of PSL was withdrawn by 10 mg alternative day every 2 months and finally discontinued at 6th month. 3. Tonsillectomy: it is done between 1-6 months by otorhinolaryngologist. 4. Antiplatelets (dilazep dihydrochloride): it is administerd orally at a dose of 300 mg /day for 24 months. 5. At 12th month, candesartan is restarted if patients did not achieve remission of proteinuria.Candesartan is restarted with the dose of 2-8mg oral tablet once daily and increased the dose up to 12 mg once daily if patients did not achieve remission of proteinuria for next 12 months. The dose prescribed at discretion of treating clinician based on individual patient characteristics.
Sponsors
Cardiovascular medicine, nephrology and neurology, University of the Ryukyus
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1.Histologically proven Ig A nephropathy patients 2.Serum creatinine levels is < 1.5 mg/dl 3.Urinary protein excretion is equal to and more than 0.5g/g creatinine and urinary red blood cell counts is equal to and more than 10/high power field 4.Histologically proven focal active lesion
Exclusion criteria
1.Recent onset of cardiovascular disease 2.Severe hypertension (high systolic blood pressure >200mmHg or high diastolic blood pressure >100mmHg 3.Diabetes mellitus 4.Patient on angiotensin converting enzyme inhibitors (ACEI) or other angiotensin receptor blockades (ARB)
Outcome results
None listed