| CTRI Number |
CTRI/2025/07/090048 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How common is kidney disease in rural Lucknow? |
|
Scientific Title of Study
|
Prevalence of chronic kidney disease in a rural population in Lucknow district – a cross-sectional screening study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Rao S |
| Designation |
Additional Professor, Department of Nephrology |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09454360872 |
| Fax |
|
| Email |
snamratarao@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Namrata Rao S |
| Designation |
Additional Professor, Department of Nephrology |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09454360872 |
| Fax |
|
| Email |
snamratarao@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Rao S |
| Designation |
Additional Professor, Department of Nephrology |
| Affiliation |
Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
| Address |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow
UTTAR PRADESH
226010
India |
| Phone |
09454360872 |
| Fax |
|
| Email |
snamratarao@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| International Society of Nephrology, Global Operations Center, Avenue des Arts 1-2: Brussels, Belgium; PINCODE: 1210
Email: info@theisn.org |
|
|
Primary Sponsor
|
| Name |
Dr Namrata Rao S |
| Address |
Department of Nephrology, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow, India, PIN - 226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Namrata Rao S |
RHTC Juggaur, Lucknow |
Department of Nephrology, Dr.Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomti Nagar, Lucknow, India, PIN - 226010
Lucknow
UTTAR PRADESH |
09454360872
snamratarao@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community residents 18 years of age from Juggaur, Uttar Pradesh to undergo preventive screening for chronic kidney disease
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Screening for chronic kidney disease in adult population in Juggaur, Lucknow |
Screening will be done using questionnaire, blood pressure, blood for serum creatinine estimation and urine for urine albumin creatinine ratio single time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult male or female more than 18 years of age residing in Juggaur, Lucknow and providing informed consent |
|
| ExclusionCriteria |
| Details |
Individuals less than 18 years of age
Those with residence in the area of interest less than 1 year
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the prevalence of chronic kidney disease in the adult population of Juggaur in rural Lucknow |
To assess the prevalence of chronic kidney disease in the adult population of Juggaur in rural Lucknow - at single timepoint 0 (at baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the risk factors associated with chronic kidney disease in the adult population of Juggaur in rural Lucknow |
To study the risk factors associated with chronic kidney disease in the adult population of Juggaur in rural Lucknow - at single timepoint 0 (baseline) |
|
|
Target Sample Size
|
Total Sample Size="2258"
Sample Size from India="2258"
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)
|
15/07/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [snamratarao@yahoo.co.in].
- For how long will this data be available start date provided 30-11-2027 and end date provided 30-11-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic kidney disease of unknown etiology also called as CKDu constitutes substantial proportion of CKD in tropical countries including India. It is unclear whether endemic nephropathies corresponding to CKDu exist in northern India such as the region of interest of the present study in central Uttar Pradesh. Therefore, the present study aims to estimate prevalence of CKD including CKDu in a rural population in Lucknow. Upto 2258 healthy individuals pertaining to Juggaur will be enrolled in the study which is a prospective, observational cross sectional study. In this study, apart from questionnaire, anthropometric measurements, urine and blood samples will also be drawn single time and established definitions will be used to establish the diagnosis of CKD and CKDu. |