| CTRI Number |
CTRI/2025/03/083747 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the Clinicopathological Features and Prevalence of patents with IgA Nephropathy from a Tertiary Care Hospital in Central India |
|
Scientific Title of Study
|
PREVALENCE AND CLINICO PATHOLOGICAL PROFILE OF IgA NEPHROPATHY IN A TERITIARY CARE HOSPITAL IN CENTRAL INDIA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Jeyachandran |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
DEPARTMENT OF NEPHROLOGY
Datta Meghe Institute of Higher Education and Research Datta
Meghe Institute of Higher Education and Research
sawnge meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9443363154 |
| Fax |
|
| Email |
vijayjeyachandran2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Jeyachandran |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
DEPARTMENT OF NEPHROLOGY
Datta Meghe Institute of Higher Education and Research Datta
Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9443363154 |
| Fax |
|
| Email |
vijayjeyachandran2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manish Balwani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
DEPARTMENT OF NEPHROLOGY
Datta Meghe Institute of Higher Education and Research Datta
Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
9443363154 |
| Fax |
|
| Email |
balwani.manish@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical Sciences Sawangi (Meghe) Wardha,MAHARASHTRA , INDIA
PIN CODE - 442001 |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Jeyachandran |
Jawarharlal Nehru Medical College |
Department of nephrology Sawangi (Meghe) Wardha- 442107
Wardha
MAHARASHTRA |
9443363154
vijayjeyachandran2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N048||Nephrotic syndrome with other morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients of age more than 18 years diagnosed to have IgAN and on regular follow up.
2. All patients with IgAN on maintenance hemodialysis.
3. All newly diagnosed patients with IgAN.
4. All patients presenting to nephrology OPD with renal biopsy proven IgAN or willing for renal biopsy to be done in the department of nephrology in the past 4 yrs. |
|
| ExclusionCriteria |
| Details |
1.All patients with age less than 18 yrs.
2. All patients with psychosocial illness or condition that may curtail their ability to consent or fulfill inclusion criteria no : 4.
3. All patients with systemic lupus erythematosis,
henoch scholein purpura or liver disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the prevalence of IgA nephropathy from a
tertiary care hospital in central India |
baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the varied symptoms/ syndromic
presentation of IgAN .
2. To analyze the clinical profile of the patients based on biochemical parameters and determine the natural
history of the patients in Indian population.
3. To determine the severity of IgAN based on renal
biopsy at presentation.
4. To determine the demographic, age and gender
variation in the presentation of the disease in central
India |
All parameters will be assessed at the baseline
at the time of enrollment.
|
|
|
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)
|
30/04/2025 |
| 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="2"
Months="0"
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
|
A study conducted in a rural tertiary care hospital in Central India aiming to investigate the prevalence and clinic pathological profile of IgA nephropathy (IgAN) patients. The rationale behind the study is to assess cost-effective investigations for diagnosing and potentially improving patient outcomes. The study design is a cross-sectional study with a duration of 24 months, conducted at Acharya Vinoba Bhave Rural Hospital. The sample size is determined to be 100 patients meeting specific inclusion criteria. Data collection involves obtaining baseline demographic and clinical data, including age, gender, BMI, and blood pressure, and analyzing serum samples for various biochemical markers. Ethical considerations, including patient confidentiality and informed consent, are emphasized. The primary outcome is to determine the prevalence of IgA nephropathy from a tertiary care hospital in central India.. The abstract highlights the study’s potential contributions to IgAN clinicopathological profile and management in the rural Indian population. |