| CTRI Number |
CTRI/2022/09/045596 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
14/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits and side effects of Dapagliflozin medicine in diabetic patients with kidney disease. |
|
Scientific Title of Study
|
Efficacy and Safety of Dapagliflozin in progression of Chronic Kidney Disease in patients with type 2 Diabetes Mellitus: A Randomised Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupinder Singh Kalra |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College, Delhi |
| Address |
Room no- 160, Department of Pharmacology, Maulana azad Medical College, Delhi
New Delhi
DELHI
110002
India |
| Phone |
9810785004 |
| Fax |
|
| Email |
drbskalra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupinder Singh Kalra |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College, Delhi |
| Address |
Room no- 160, Department of Pharmacology, Maulana azad Medical College, Delhi
New Delhi
DELHI
110002
India |
| Phone |
9810785004 |
| Fax |
|
| Email |
drbskalra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kritika |
| Designation |
PG Resident 1st year |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Room no-162, Department of Pharmacology, Maulana Azad Medical College, Delhi
New Delhi
DELHI
110002
India |
| Phone |
8799741992 |
| Fax |
|
| Email |
kritzyadav5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College Delhi |
| Address |
Bahadur Shah Zafar Marg, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Kritika |
Lok Nayak Hospital |
Department of pharmacology Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI |
08799741992
kritzyadav5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SGLT 2 Inhibitors (Sodium Glucose Co-transporter) |
SGLT 2 Inhibitors given for retarding the progression of chronic kidney disease in Diabetic patients. |
| Comparator Agent |
Tab Dapagliflozin
|
In one group, Tab Dapagliflozin 10mg Once a day for 6 months is given, In other group Standard of care is given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with diagnosis of CKD with type 2 Diabetes Mellitus with HbA1c<8% who had-
eGFR of 30-60ml/min/1.73m2
Urinary Albumin to Creatinine ratio 200-5000mg/g
2. Patients who are on ACE inhibitors or ARBs for at least 4 weeks before screening. |
|
| ExclusionCriteria |
| Details |
1. Patients with Type 1 diabetes, lupus nephritis, Rheumatoid arthritis, Cancer and
Neurodegenerative disorders
2. Patients have received immunosuppressive therapy within 6 months.
3. Pregnant patients and nursing mothers. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in eGFR
Change in UACR |
0, 3, 6 months after starting drug therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in IL-6 levels
|
0, 6 months after starting drug therapy |
| Change in HbA1c levels |
0, 3, 6 months after starting drug therapy |
Frequency of hypoglycemic episodes
|
0, 3, 6 months after starting drug therapy
|
| Safety Profile in both groups |
0, 3, 6 months after starting drug therapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/09/2022 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic Kidney Disease is highly prevalent at 17.2% in the Indian population and prevalence of CKD in Diabetes patients is 25%. It is irreversible, progressive disorder and is associated with high cardiovascular risk. The common causes for CKD include Diabetes, Hypertension, chronic use of NSAIDs, Chronic glomerulonephritis etc. Long standing or uncontrolled Diabetes has been associated with development of CKD. Current management for retarding the progression of CKD is linked with control of Diabetes, hypertension and other complications. Angiotensin Converting Enzyme inhibitors, Angiotensin II receptor blockers, phosphate binders etc are presently being prescribed to slow down the progression. Dapagliflozin is a reversible inhibitor of the Sodium Glucose co transporter 2 (SGLT2), which is responsible for glucose reabsorption in the kidney. It is highly selective drug which acts directly by elimination of glucose and thereby reducing blood glucose levels in type 2 Diabetes patients. Dapagliflozin acts by restoration of tubuloglomerular feedback, recing workload by restricting the reabsorption and mitigating hypoxia. It would be useful to know efficacy and safety of Dapagliflozin in slowing the progression of CKD in patients with Diabetes in Indian population. Hence, we propose to do this study.
|