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CTRI Number  CTRI/2023/05/052593 [Registered on: 12/05/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dual RAAS blockage in primary glomerular diseases 
Scientific Title of Study   Randomized Control Trial to study the safety and efficacy of dual blockade of Renin Angiotensin Aldosterone System (RAAS) in Primary Glomerular diseases. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tukaram Jamale 
Designation  Prof and Head of department of Nephrology 
Affiliation  Seth GSMC and KEM hospital Mumbai 
Address  34 A third floor Department of Nephrology Old building KEM Hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  09167460362  
Fax    
Email  tukaramjamale@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Tukaram Jamale 
Designation  Prof and Head of department of Nephrology 
Affiliation  Seth GSMC and KEM hospital Mumbai 
Address  34 A third floor Department of Nephrology Old building KEM Hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  09167460362  
Fax    
Email  tukaramjamale@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Tukaram Jamale 
Designation  Prof and Head of department of Nephrology 
Affiliation  Seth GSMC and KEM hospital Mumbai 
Address  34 A third floor Department of Nephrology Old building KEM Hospital Parel Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  09167460362  
Fax    
Email  tukaramjamale@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Nephrology KEM Hospital Parel Mumbai 400012 
 
Primary Sponsor  
Name  Department of Nephrology 
Address  34 A Third floor old building KEM Hospital Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tukaram Jamale   King Edward Memorial Hospital, Mumbai  34 A third floor Department of Nephrology Old building KEM Hospital Parel Mumbai 400012 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 09167460362

tukaramjamale@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N005||Acute nephritic syndrome with diffuse mesangiocapillary glomerulonephritis, (2) ICD-10 Condition: N001||Acute nephritic syndrome with focal and segmental glomerular lesions, (3) ICD-10 Condition: N003||Acute nephritic syndrome with diffuse mesangial proliferative glomerulonephritis, (4) ICD-10 Condition: N041||Nephrotic syndrome with focal andsegmental glomerular lesions, (5) ICD-10 Condition: N042||Nephrotic syndrome with diffuse membranous glomerulonephritis, (6) ICD-10 Condition: N045||Nephrotic syndrome with diffuse mesangiocapillary glomerulonephritis, (7) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Losartan  Primary glomerular disease patient who have received Tablet Losartan 100mg per day for atleast 4 weeks will be continued with tablet losartan 
Intervention  Losartan plus Enalapril  Primary glomerular disease patient who have received Tablet Losartan 100mg per day for atleast 4 weeks will be given Tablet Enalapril which will be uptitrated to maximum tolerated dose 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients with primary glomerular diseases – MN, FSGS, IgAn, iMPGN, MCD

2. Patients with who have received single RAAS blocking agent (LOSARTAN 100 mg) for atleast 4 weeks and having proteinuria more than 500 mg/day

3. Age >12 years

4. Either sex 
 
ExclusionCriteria 
Details  1. Secondary glomerulonephritis.

2. Prior history of angioedema

3. Bilateral renal artery stenosis

4. Pregnancy

5. Serum Potassium more than 5.1 mmol/L

6. eGFR < 30 ml/min 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the incidence and severity of adverse event related to RAAS inhibition in patients with primary glomerular diseases  1 year 
 
Secondary Outcome  
Outcome  TimePoints 

1. To study the decrease in proteinuria at the end of 1styear post randomization

2. To study the reduction in decline in eGFR at the end of 1styear post randomization

3. To study the incidence of other adverse events related to ACEI (dry cough, angioedema) 		 1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Glomerular diseases are one of the most important causes of chronic kidney disease in worldwide. They are leading cause of end stage renal disease in developing countries. Primary glomerular diseases mainly include Minimal change disease (MCD), Focal segmental glomerulosclerosis (FSGS), IgA Nephropathy (IgAN), idiopathic membranoproliferative glomerulonephritis (MPGN) and Membranous nephropathy (MN). Inhibition of Renin angiotensin aldosterone system (RAAS) is cornerstone of management of proteinuria in addition to immunosuppression. Number of trials and metanalysis have demonstrated that combination of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) have greater antiproteinuric effect than either agents alone.Publications of trials involving patients with diabetes demonstrated adverse effects of combined RAAS blockade. Uncertainty regarding the adverse effects with use of dual RAAS blockage prevents its use in primary glomerular diseases. Further trials are needed to study the combination therapy as evidence based practice. We wish to evaluate safety and efficacy of dual RAAS blockage in patients with primary glomerular diseases.
 
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