The efficacy of supportive treatment in IgA nephropathy

Recruiting

Conditions: Patients with biopsy proven primary IgA nephropathy with proteinuria equal to or more than 1g/day and eGFR more than 30ml/min/1.73m2

Registration Number: CTRI/2018/01/011414

Brief Summary: IgA nephropathy(IgAN) is the most common primary glomerular disease in adults. 10-40%patients with IgAN progress to End Stage Kidney Disease (ESKD) in 10-20 years. The severity of disease and risk of progression has been shown to vary with ethnicity and Asians including Indians have been reported to have more severe disease.There is a lack of consensus about the optimumtreatment strategy for IgA nephropathy. It is widely accepted and also recommended by the KDIGO guidelines that All patients with IgAN should receive adequatesupportive therapy comprising of adequate blood pressure control and reninangiotensin system blockade(RASB) using Angiotensin converting enzyme inhibitors(ACEi) and/or Angiotensin receptor blockers (ARBs). Immunosuppression should be considered only if patients do not respond to this treatment in 3-6months. However since the disease is apparently has a more severe phenotype in Indians, the efficacy of supportive therapy in these patients needs to be assessed.

Patients with biopsy proven IgAN with 24 hoururinary proteinâ‰¥1g/day and eGFRâ‰¥30ml/min/1.73m2 will be included inthe study after taking informed consent. Each kidney biopsy will be assignedthe MEST-C score as per the Oxford classification by the reviewingpathologists. All patients will bemanaged with RASB using an ACEi(Incremental dose with maximum tolerable dose) oran ARB (if the patient is intolerant to ACEi), unless contraindicated. Thetarget blood pressure will be â‰¤130/80mm of Hg. The dose of the ACEi/ARB usedwill be gradually increased to the maximum approved daily dose or tothe maximum tolerable dose, which is usually given to these patients. Patientswill be counselled to avoid taking other nephrotoxic agents including over thecounter non-steroidal anti-inflammatory drugs, potassium sparing diuretics etc.Female patients will be counselled to avoid pregnancy.Dyslipidemia if present, will be treated as per existing guidelines.

Patients will befollowed prospectively every month in the renal clinic till the primary outcome till 6 months. Patients who achieve response who will be further follow up till 5 years to look for sustained response

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Biopsy proven primary IgA nephropathy with proteinuriaâ‰¥1g/day.

Exclusion Criteria

1.Lack of informed consent 2.eGFR<30ml/min/1.73m2 3.Presence of crescents on kidney biopsy 4.History of immunosuppressive therapy in last 6 months for more than 2 weeks 5.
Past history of use of Angiotensin converting enzyme inhibitors(ACEi) or Angiotensin receptor blockers(ARBS) in the previous 6 months 5.Patients with a second coexisting disease on kidney biopsy like diabetic nephropathy 6.Secondary causes of IgA nephropathy like chronic liver disease, Henoch Schonlein Purpura 7.Patient who is pregnant or breast feeding at the time of recruitment.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achieving complete or partial remission:	Patients will be followed up monthly for 6months. Those who achieve the primary outcome will be then followed up till 5 years to look for sustained response
Complete remission: Proteinuria les than 0.5g/day with no greater than 25% decline in eGFR.	Patients will be followed up monthly for 6months. Those who achieve the primary outcome will be then followed up till 5 years to look for sustained response
Partial remission:Atleast 50% decline in proteinuria from the baseline with no greater than 25% decline in eGFR	Patients will be followed up monthly for 6months. Those who achieve the primary outcome will be then followed up till 5 years to look for sustained response
No response: Less than 50% reduction, unchanged/increasing 24 hour proteinuria from baseline and/or 50% or more decline in eGFR or progression to end stage renal disease which cannot be attributed to any other cause.	Patients will be followed up monthly for 6months. Those who achieve the primary outcome will be then followed up till 5 years to look for sustained response

Secondary Outcome Measures

Name	Time	Method
Renal deterioration:50% or more decline in eGFR or progression to end stage renal disease which cannot be attributed to any other cause.

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Soumita Bagchi
Principal investigator
9871911744
soumita_bagchi@yahoo.co.in