| CTRI Number |
CTRI/2023/11/060195 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare combination therapy of diabetic and anti hypertensive drugs with only anti hypertensive drug in patients with Chronic kidney disease |
|
Scientific Title of Study
|
A randomized controlled trial to compare the efficacy of combination therapy of SGLT2 inhibitor and ARB to ARB monotherapy on clinical outcomes in patients with CKD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nithesh Babu R |
| Designation |
Postgraduate, General Medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9600057515 |
| Fax |
|
| Email |
nithesh5596@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahendra Kumar K |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9445645171 |
| Fax |
|
| Email |
mahindran1985@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahendra Kumar K |
| Designation |
Professor, General Medicine |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105
TAMIL NADU
602105
India |
| Phone |
9445645171 |
| Fax |
|
| Email |
mahindran1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
|
|
Primary Sponsor
|
| Name |
Dr Nithesh Babu R |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105 |
| 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 Nithesh Babu R |
Saveetha Medical College Hospital |
Room no 1,
Department of General Medicine,
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU |
9600057515
nithesh5596@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin and Telmisartan |
Dapagliflozin 10 mg OD, po for 3 months
Telmisartan 40 mg OD, po for 3 months |
| Comparator Agent |
Telmisartan |
40 mg OD, po for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Gfr greater than 25 ml/min/m2
2. Urine albumin creatinine ratio greater than 30 mg/g with or without hypertension
3. Type 2 Diabetes mellitus
4. Hypertension |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent
2. Patients with end stage renal disease
3. Patients with acute renal failure
4. Patients with albumin creatinine ratio less than 30 mg/g
5. Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of EGFR and Urine albumin creatinine ratio |
Every month for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, lipid profile, serum creatinine, HbA1c, fasting glucose and rates of clinical adverse events such as myocardial infarction, stroke or end-stage renal disease |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
15/12/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized, double blinded, parallel group, single centre trial comparing the efficacy of combination therapy of dapagliflozin 10mg daily and telmisartan 40 mg daily for 3 months with telmisartan 40 mg daily alone for 3 months in patients with chronic kidney disease. A total of 78 patients are to be included in the trial. The primary outcome is change in eGFR and urine albumin creatinine ratio which will be measured every month for 3 months. The secondary outcomes are changes in Blood pressure, serum creatinine, fasting glucose, HBa1c, lipid profile and rates of clinical adverse events such as myocardial infarction, stroke or end-stage renal disease at 3 months. |