| CTRI Number |
CTRI/2019/05/019025 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
20/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Progression and heart related outcomes of kidney disease |
|
Scientific Title of Study
|
Progression and cardiovascular outcomes of chronic kidney disease in a community: a pharmacoepidemiologic perspective |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Abdul Khader |
| Designation |
Research Scholar |
| Affiliation |
KMC, Manipal |
| Address |
Department of Nephrology, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8073860114 |
| Fax |
|
| Email |
nisha.ak@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Ravindra Prabhu Attur |
| Designation |
Professor and Unit Head |
| Affiliation |
KMC, Manipal |
| Address |
Department of Nephrology, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Ravindra Prabhu Attur |
| Designation |
Professor and Head |
| Affiliation |
KMC, Manipal |
| Address |
Department of Nephrology, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Udupi District, Karnataka
Pincode: 576104
|
|
|
Primary Sponsor
|
| Name |
Griffith University |
| Address |
Gold Coast Campus, Griffith University QLD 4222 |
| Type of Sponsor |
Other [Academic Institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravindra Prabhu |
Rural Maternity and Child Health Welfare center Kadekar |
Behind Syndicate bank, Kadekar, Udupi, Karnataka
Pin code: 576101 Udupi KARNATAKA |
9448107771
ravindra.prabhu@manipal.edu |
| Ravindra Prabhu |
Rural Maternity and Child Health Welfare center, Alevoor |
Near Nehru High School, Marne road, Alevoor, Udupi
Pin code:574118
Udupi KARNATAKA |
9448107771
ravindra.prabhu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N18||Chronic kidney disease (CKD), |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the consenting adults in the previous community-based study conducted as a part of SEEK project 9 years back will be included. Subjects who were detected to have CKD (eGFR ≤60 ml/min/1.73m2) will be included for the complete study. Those subjects without CKD in the previous study will also be included to assess mortality and to find new CKD in these subjects.
|
|
| ExclusionCriteria |
| Details |
Adults not belonging to the previous cohort. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Estimated GFR and progression of CKD
2) Mortality |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Cardiovascular outcome
2)Quality of Life
3) CKD registry |
3 years |
|
|
Target Sample Size
|
Total Sample Size="1331" Sample Size from India="1331"
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)
|
20/05/2019 |
| 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="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)?
|
|
Brief Summary
|
We plan to follow up the rural population screened nine years back as part of Screening and Early Evaluation of Kidney Disease (SEEK) project. Ours was a community-based study, where the investigator did house to house survey as compared to SEEK project which was camp-based done elsewhere. This population continues to be rural based and is under the field practice area of our community medicine department. We expect to be able to follow them up with previously available identifiers. We found a prevalence of CKD of about 32.1 % and identified patients were requested to visit a tertiary care set up but follow up was poor as most were asymptomatic. We plan to study the progression in those identified to have CKD with cardiovascular outcomes and identify new cases if any of those who did not have CKD earlier. The prevalence of the risk factors of CKD is increasing in the South Asian population, this adds for the increased prevalence of CKD in these population. South Asian population face a higher burden of CKD and cardiovascular disease. There is paucity of data on the progression and cardiovascular outcomes of CKD in Indian setup. This is a prospective cohort study which will be conducted for 12 months. Consequence of this study is of great benefit to the community. It would help to sensitize the public and healthcare professionals regarding the impact of CKD on public health and may help in the formulation of preventive health policies and allotment of reliable resources for the treatment of this disease, which is crucial in India. It would also aid in strengthening the validity of MDRD formula in India. |