| CTRI Number |
CTRI/2014/09/004964 [Registered on: 03/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
02/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to determine whether the renalase gene is associated with chronic kidney disease.
|
|
Scientific Title of Study
|
Association of single nucleotide Polymorphisms in the renalase gene with chronic kidney disease in an Indian population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Mullasari |
| Designation |
Director of Cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No4A Dr J J Nagar Mogappair Chennai 600037
No 4A Dr J J Nagar Mogappair Chennai 600037
Chennai
TAMIL NADU
600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
clireco@mmm.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajit Mullasari |
| Designation |
Director of Cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No4A Dr J J Nagar Mogappair Chennai 600037
No 4A Dr J J Nagar Mogappair Chennai 600037
TAMIL NADU
600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
clireco@mmm.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajit Mullasari |
| Designation |
Director of Cardiology |
| Affiliation |
The Madras Medical Mission Hospital |
| Address |
No4A Dr J J Nagar Mogappair Chennai 600037
No 4A Dr J J Nagar Mogappair Chennai 600037
TAMIL NADU
600037
India |
| Phone |
044-26565974 |
| Fax |
044-26565974 |
| Email |
clireco@mmm.org.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
The Madras Medical Mission |
| Address |
No 4A Dr J J Nagar Mogappair Chennai 600037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajit Mullasari |
The Madras Medical Mission Hospital |
No4A DrJ J nagar mogappair chennai 600037
Chennai
TAMIL NADU |
04426565974
04426565974
clireco@mmm.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
confirmed Chronic Kidney desease patients with GFR less than 60mL/min/1.73m2, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
GFR less than 60mL/MIN/1.73M2 |
|
| ExclusionCriteria |
| Details |
Cancer Hepatitis positive HIV positive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the potential association of candidate SNPs in the renalase gene in CKD patients |
To investigate the potential association of candidate SNPs in the renalase gene in CKD patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to predict early diagnosis of CKD. |
to predict early diagnosis of CKD. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
14/06/2014 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Blood samples collected from CKD patients to see the amount of renalase gene. |