| CTRI Number |
CTRI/2021/11/038338 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Multinational, observational study |
| Study Design |
Other |
|
Public Title of Study
|
Real world data on patient management and quality of care |
|
Scientific Title of Study
|
Prospective, Multinational, observational registry utilizing a cloud-based eCRF accessible to investigators. This registry will be open to all physicians managing T2DM, HF or CKD across the world |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D1690R00044 version 3.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Banshi Saboo |
| Designation |
Chief Diabetologist |
| Affiliation |
Diabetes care and hormone clinic |
| Address |
1 & 2, Gandhi Park, Near Nehrunagar Road, Opp, BRTS, L Colony, Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
|
| Fax |
|
| Email |
banshisaboo98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharath HS |
| Designation |
Study Physician |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, OuterRing Road
Bangalore
KARNATAKA
560045
India |
| Phone |
9902011779 |
| Fax |
|
| Email |
bharath.hs@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Amit Kumar |
| Designation |
Head – Trials, Publications and Medical Excellence |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, OuterRing Road
Bangalore
KARNATAKA
560045
India |
| Phone |
9972365541 |
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
N1 Block,12th Floor, Manyatha Tech Park Bangalore, KARNATAKA 560045, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Costa Rica
Egypt
Ethiopia
Georgia
Greece
India
Indonesia
Lebanon
Malaysia
Mexico
Philippines
Russian Federation
Saudi Arabia
Singapore
South Africa
Thailand
Ukraine
United Arab Emirates |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ranjan Sarkar |
AMRI Hospital |
Department of Nephrology, JC Block Lane, Saltlake, Central Park Road Broadway Road, stadium gate number 3, opposite salt lake, Sector III, Bidhannagar, Kolkata, West Bengal 700098
Kolkata
WEST BENGAL |
9830020762
ranjansarkar1964@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AMRI Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, (2) ICD-10 Condition: N189||Chronic kidney disease, unspecified, (3) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. ≥18 years old
2. Having type 2 diabetes, CKD and/or HF
3. Providing written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Having any life-threatening co-morbidity and a life expectancy of less than 1 year
2. Participating in any interventional trial requiring informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Data on real-world management of either/or cardiovascular diseases, T2DM and/or CKD
2. Long-term data collection
3. Truly global data capture
4. Quality KPIs for benchmarking and improving quality of care |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine risk factors associated with progression of microvascular and macrovascular disease complications, patient outcomes, loss of quality of life, and increased healthcare resource utilization during follow-up |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="8500"
Sample Size from India="2500"
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)
|
01/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2017 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Heart Failure and Chronic Kidney Disease |