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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N18||Chronic kidney disease (CKD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 

 
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