to know the effect of capsule budesonide on protein leak from kidney and filtration function of the kidney in persons having IgA nephropathy
Phase 3
Completed
- Conditions
- Health Condition 1: N08- Glomerular disorders in diseases classified elsewhere
- Registration Number
- CTRI/2021/02/031480
- Lead Sponsor
- Department of NephrologyIPGMER SSKM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 53
Inclusion Criteria
Biopsy verified IgA nephropathy
24 hour urinary protein more than or equal to one gram
eGFR of atleast 45 ml per minute per 1.73 square metre or more
informed consent
Exclusion Criteria
Uncontrolled blood pressure ( treated or untreated) defined as systolic blood pressure more than or equal to 160 mmHg and diastolic blood pressure more than or equal to 100 mmHg.
Patients who are pregnant or breast feeding their child or unwilling to use adequate contraception during the study (only women of child bearing potential).
Liver disease , Diabetes mellitus ,current or history of malignancy.
History or presence of psychological or psychiatric illness.
Acute or chronic infections.
IFTA in renal biopsy more than 30%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in 24 hour urinary protein. <br/ ><br>- Change in estimated glomerular filtration rate. <br/ ><br>Timepoint: Patients will attend visits at 0,1,3,6, 7.5,9 months and whenever necessary
- Secondary Outcome Measures
Name Time Method 1.Change in blood pressure and antihypertensive requirement. <br/ ><br>2.Presence or absence of microhematuria. <br/ ><br>3.Rate of serious adverse events( death or non elective hospitalisation). <br/ ><br>Timepoint: At months 1,3,6,7.5 , 9