Health Condition 1: N08- Glomerular disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Budesonide controlled release capsule ,9 mg each capsule ,two capsules to be taken orally once daily one hour before breakfast for 9 months: oral capsule of budesonide to be taken one
Sponsors
Department of NephrologyIPGMER SSKM Hospital
Eligibility
Inclusion criteria
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
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%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24 hour urinary protein. - Change in estimated glomerular filtration rate. Timepoint: Patients will attend visits at 0,1,3,6, 7.5,9 months and whenever necessary | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in blood pressure and antihypertensive requirement. 2.Presence or absence of microhematuria. 3.Rate of serious adverse events( death or non elective hospitalisation). Timepoint: At months 1,3,6,7.5 , 9 | — |
Countries
India
Contacts
Public ContactDr Pradeep Kumar Das
IPGMER and SSKM Hospital
Outcome results
None listed