| CTRI Number |
CTRI/2022/04/042214 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
26/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To study a new blood test to diagnose the most common kidney disease called Ig A nephropathy |
|
Scientific Title of Study
|
Utility of Serum Galactose Deficient for Ig A nephropathy: Prospective study from A Tertiary care center in South India" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sree Bhushan Raju |
| Designation |
Professor & Head |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
500082
Hyderabad
TELANGANA
500082
India |
| Phone |
9030292929 |
| Fax |
|
| Email |
sreebhushan@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sree Bhushan Raju |
| Designation |
Professor & Head |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
500082
Hyderabad
TELANGANA
500082
India |
| Phone |
9030292929 |
| Fax |
|
| Email |
sreebhushan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sree Bhushan Raju |
| Designation |
Professor & Head |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana
500082
Hyderabad
TELANGANA
500082
India |
| Phone |
9030292929 |
| Fax |
|
| Email |
sreebhushan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MRU Project,
NIMS, Panjagutta,
Hyderabad
Telangana
500082 |
|
|
Primary Sponsor
|
| Name |
MRU |
| Address |
NIMS, Pnajagutta, Hyderabad |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ministry of Health family Welfare |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sree Bhushan Raju |
Nizams Institute of Medical Sciences |
Dept of Nephrology,
Nizams Institute of Medical Sciences
Panjagutta, Hyderabad
9030292929
sreebhushan@hotmail.com
Hyderabad
TELANGANA |
9030292929
sreebhushan@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N033||Chronic nephritic syndrome with diffuse mesangial proliferative glomerulonephritis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with biopsyy proven primary IgA nephropathy |
|
| ExclusionCriteria |
| Details |
(1) Who do not give informed consent.
(2) Has history of immunosuppression use before sample collection.
(3) Has secondary causes of IgAN like chronic liver disease
(4) Henoch-Schonlein purpura
(5) a coexisting systemic disease features like diabetic nephropathy
(6) inadequate kidney biopsy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) 50 % fall from initial eGFR
b) ESRD – either estimated creatinine clearance 15 ml/mt or initiation of renal replacement therapy (PD/HD)
c) Death
|
4 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
2 years |
| Infections during the clinical course of the disease |
2 years |
| Cardiovascular complications during the study period |
2 years |
| Hospitalizations |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/05/2022 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sreebhushan@hotmail.com].
- For how long will this data be available start date provided 22-04-2022 and end date provided 22-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is a single center, prospective, observational study to to assess utility of galactose deficient IgA1 as a diagnostic marker for IgA nephropathy and to correlate the levels of galactose deficient IgA1 with severity of progression. We will be recruiting 50 patients ( age 2-80 years) with biopsy proven Ig A nephropathy not yet initiated on any immunosuppressive therapy. Demographic, clinical and laboratory (Including but not limited to serum creatinine, serum albumin and serum cholesterol and urinary protein creatinine ratio) will be recorded. Estimated glomerular filtration rate(eGFR) will be calculated using the 4 variable Modification of Diet in Renal Disease (MDRD) formula or CKD- EPI formula for adults and the revised Schwartz formula for those who were <18 years of age. Renal biopsy(LM,IF and EM) findings will be noted. Gd-IgA1 level in serum will be measured by solid phase sandwich enzyme immunoassay kit (IBL international GmBH, Germany) following the manufacturer’s instructions. Patients will be initiated on guideline based therapy and followed up with investigations once in 3-4 months for a period of 24 months. Similarly, controls will be taken from non Ig A gloemerular diseases such as memebranous nephropthay and FSGS. Study end points are defined as 1. more than 50 % fall from initial eGFR 2. ESRD – either estimated creatinine clearance <15 ml/mt or initiation of renal replacement therapy(RRT) and 3. death
|