| CTRI Number |
CTRI/2024/02/062222 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness and Safety of Budesonide in Primary IgA Nephropathy (IgAN) patients |
|
Scientific Title of Study
|
A Prospective, Double-Blind, Multicentric, Randomized,
Placebo-controlled Clinical Trial to Evaluate the Efficacy and
Safety of Budesonide in Patients With Primary IgA Nephropathy(IgAN) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MC/BDS/23-009 Version 1.0 dated 7 Sep 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narayan Prasad |
| Designation |
Prof. and Head, Department of Nephrology |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, C block, 2nd Floor, Raebareli Road, Lucknow, Uttar Pradesh- 226014, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904352 |
| Fax |
|
| Email |
narayan.nephro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Prasad |
| Designation |
Prof. and Head, Department of Nephrology |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, C block, 2nd Floor, Raebareli Road, Lucknow, Uttar Pradesh- 226014, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904352 |
| Fax |
|
| Email |
narayan.nephro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Prasad |
| Designation |
Prof. and Head, Department of Nephrology |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, C block, 2nd Floor, Raebareli Road, Lucknow, Uttar Pradesh- 226014, India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904352 |
| Fax |
|
| Email |
narayan.nephro@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fourrts (India) Laboratories Pvt. Ltd.
Plot No-1, Fourrts Avenue,
Annai Indira Nagar,
Okkiyam Thoraipakkam,
Chennai-600097 |
|
|
Primary Sponsor
|
| Name |
Fourrts (India) Laboratories Pvt. Ltd. |
| Address |
Plot No-1, Fourrts Avenue,
Annai Indira Nagar,
Okkiyam Thoraipakkam,
Chennai-600097 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSoumita Bagchi |
All India Institute Of Medical Science |
Department of Nephrology, Ansari Nagar,Delhi-110029
New Delhi
DELHI |
9871911744
soumita_bagchi@yahoo.co.in |
| Dr Rajeev A Annigery |
Apollo Hospitals, Chennai |
Department of Nephrology, No.-21, Greams Lane, Off Greams Road, Chennai-600 006
Chennai
TAMIL NADU |
9840073880
rajeevnephro@gmail.com |
| Dr Manjuri Sharma |
Gauhati Medical College and Hospital |
Department of Nephrology, Bhangagarh, Guwahati-781032, Assam
Kamrup
ASSAM |
9435553482
manjurisharma@yahoo.com |
| Dr Koushik Bhattacharjee |
IPGME&R, SSKM Hospital |
Department of Nephrology, 1st Floor, 242 AJC Bose Road, Kolkata-700020
Kolkata
WEST BENGAL |
9831123712
doc.koushikbhattacharjee@gmail.com |
| Dr Narayna Prashad |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
Department of Nephrology, C block, 2nd Floor, Raebareli Road, Lucknow, Uttar Pradesh- 226014, India
Lucknow
UTTAR PRADESH |
8004904352
narayan.nephro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE, All India Institute Of Medical Science |
Approved |
| Institutional Ethics Committee, Apollo Hospitals, Chennai |
Submittted/Under Review |
| INSTITUTIONAL ETHICS COMMITTEE, Gauhati Medical College and Hospital |
Submittted/Under Review |
| IPGME&R Research Oversight Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N08||Glomerular disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Budesonide (BUDENOFIL-9) |
Budesonide (BUDENOFIL-9: Enteric coated controlled release tablet)-9 mg to be consumed once daily one hr before breakfastr |
| Comparator Agent |
Identical Placebo tablets |
Identical Placebo tablets to be consumed once daily one hr before breakfast |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Female or male aged greater than equal to 12 years
2. Primary IgA nephropathy confirmed by the most recent renal biopsy (within the past 10 years)
3. Estimated Glomerular Filtration Rate (eGFR using CKD-EPI equation) greater than 30 mL by min per 1.73 m2 despite optimized renin-angiotensin system blockade for a minimum of 1 month and a maximum of 6 months
4. Urinary Protein Creatinine Ratio (uPCR) greater than equal to 0.8 g by g or urinary total protein greater than equal to 1 g by d
5. Willingness to provide written informed consent (or assent, as applicable) |
|
| ExclusionCriteria |
| Details |
1.Secondary IgAN (for example, IgAN associated with disorders like viral infections, autoimmune disorders, or malignancy)
2.Systemic diseases that may cause mesangial IgA deposition
3.Non-IgAN glomerulonephritis
4.History of kidney transplantation
5.Nephrotic syndrome or a rapidly progressive clinical course which would make the patient, in the opinion of the Investigator, unsuitable for the study
6.Severe histological lesions of activity/chronicity characterized by the following: endocapillary hypercellularity in >50% of examined glomeruli, crescents in >30% of examined glomeruli, presence of fibrinoid necrosis, global glomerulosclerosis in over 50% of examined glomeruli
7. History of or current acute or chronic diseases including hepatitis, tuberculosis, or human immunodeficiency virus (HIV), chronic urinary tract infections, or liver cirrhosis
8.Known diagnosis of unregulated Type I or Type II diabetes mellitus (glycated hemoglobin >8%), gastrointestinal disorders, active infections, arrhythmia or cardiovascular conditions, judged to be clinically significant as per the Investigator
9.Inadequately controlled blood pressure (i.e., systolic blood pressure/diastolic blood pressure ≥140/90 mm Hg)
10.History of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator
11.Presence of medium- or high-risk osteoporosis
12.History of glaucoma, cataract, or single-eye cataract surgery
13.Treatment with potent inhibitors of cytochrome P450 3A4(CYP3A4)
14.Life expectancy <5 years according to the Investigator
15.Pregnant or breastfeeding women, or women of child-bearing potential not in agreement to use adequate birth control methods throughout the study
16.Known allergy or hypersensitivity to the components of the study medication
17.Participation in another clinical trial within past 30 days
18.Planned participation in any other trial during the entire duration of the study
19.Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
20.Any other condition(s) which would make the patient, in the opinion of the Investigator, unsuitable for the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Urinary Protein Creatinine Ratio (uPCR) from
baseline to 3, 6, 9, and 12 months
2. Change in Urinary Albumin Creatinine Ratio (uACR) from
baseline to 3, 6, 9, and 12 months
3. Change in estimated Glomerular Filtration Rate (eGFR; calculated using the CKD-EPI formula) from baseline to 3, 6,9, and 12 months
4. Change in hematuria or proportion of subjects with hematuria from baseline to 3, 6, 9, and 12 months |
3 months, 6 months, 9 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical laboratory results for hemogram, HbA1C, and
kidney function test at baseline, and at the end of 6 and 12 months of treatment
2. Results for vital signs (pulse rate, respiratory rate, blood
pressure, and body temperature) at baseline, and at the end of 6 and 12 months of treatment |
6months, 12 months
|
Proportion of subjects with adverse events and serious
adverse events upon treatment with budesonide |
Baseline, Month 3, Month 6, Month 9, Month 12 |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
05/02/2024 |
| 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="3"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The protective effect of Budesonide on IgA Nephropathy is well researched. This study aims to evaluate the efficacy and safety of Budesonide in patients with primary IgA Nephropathy (IgAN). The primary objective is to assess the efficacy of budesonide in management of proteinuria and hematuria in subjects with primary IgA nephropathy. The secondary objective is to assess safety of budesonide in subjects with primary IgA nephropathy, based on adverse events, clinical laboratory results, and vital signs assessments. The study is designed as a Prospective, Double-Blind, Multicentric, Interventional, Randomized, Placebo-controlled, Investigator-initiated study. The study population consist of patients in the age group of ≥12 years diagnosed with primary IgA nephropathy confirmed by the most recent renal biopsy (within the past 10 years). Subjects satisfying all eligibility criteria will be enrolled from 4-5 study sites after obtaining written informed consent (or assent, as applicable). After baseline assessment, subjects will berandomized 1:1 to be administered either 9 mg budesonide or placebo. All adverse events will be recorded. Data collected at baseline and follow-up visits will be analyzed. The study visit will be as per the following schedule: Visit 1 (Day -7): Informed consent and Screening Visit 2 (Day 0): Randomization, baseline assessment, and treatment initiation Visit 3 (Day 90 ± 7 days): Follow-up visit Visit 4 (Day 180 ± 7 days): Follow-up visit Visit 5 (Day 270 ± 7 days): Follow-up visit Visit 6 (Day 360 ± 7 days): End of treatment and end-of-study visit Unscheduled visit: As required (during study participation) |