| CTRI Number |
CTRI/2024/11/076246 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dapagliflozin on Patients of Chronic Kidney Disease |
|
Scientific Title of Study
|
Effect of Dapagliflozin on Progression, Prevention of Complications and Mortality in Patients of Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DAP-CKD |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aviral Dua |
| Designation |
PG student |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of medicine
Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7982221018 |
| Fax |
|
| Email |
aviraldua27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
H K Aggarwal |
| Designation |
Senior professor and Head |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of medicine
Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
hariaggarwal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aviral Dua |
| Designation |
PG student |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak, Haryana |
| Address |
Department of medicine
Pt B D Sharma PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7982221018 |
| Fax |
|
| Email |
aviraldua27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medicine
Pt. B D Sharma PGIMS, Rohtak, Haryana, India
PIN code -124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak Haryana India |
| Address |
Department of Medicine
Pt B D Sharma PGIMS, Rohtak, Haryana, India
PIN code - 124001 |
| 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 Aviral Dua |
Pt B D Sharma PGIMS, Rohtak |
Department of Medicine
Rohtak
HARYANA |
7982221018
aviraldua27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS/UHS, Rohtak |
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 |
Tablet dapagliflozin |
Tb dapagliflozin
Dose - 10mg
Frequency - once daily
For duration of 6 months to 1 year
in patients of non-diabetic CKD |
| Comparator Agent |
Tablet Dapagliflozin |
Tb dapagliflozin
Dose -10mg
Frequency - once daily
Duration- 6months to 1 year
in patients of diabetics CKD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All who are above the age of 18 years and less than 65 years of age at the time of
consent.
• eGFR ≥30 and ≤90 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 or if there is
evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200
and ≤5000 mg/g at visit 1. |
|
| ExclusionCriteria |
| Details |
Age less than 18years or more than 65years
• Pregnancy
• Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
• History of organ transplantation
• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
• Type 1 diabetes mellitus
• New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
• Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12weeks prior to enrolment
• Any malignancy
• Chronic Urinary Tract Infection. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Dapagliflozin on slowing disease progression and preventing complication in patients of CKD. |
At baseline , then at 4weeks, then at 13 weeks, then at 26 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate its effect on various renal and cardiovascular parameters in patients of CKD
• Percentage change from baseline in 24hr proteinuria
• Changes in eGFR
• Need for Renal replacement therapy
• Number of Hospitalisation
Mortality |
At 15 days ,1 month , 3months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
11/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In India, it has been seen that mean years of developing cardiac complication is decade earlier as compared to the those in western population, moreover cardiovascular complications are the most common cause of death in patients of CKD. Though SGLT-2 inhibitors have shown a beneficial effect in decreasing progression of disease in western population butthere are very few studies done on Indian population. Hence our study is planned to see the effect of dapagliflozin on progression of disease in patients of CKD |