| CTRI Number |
CTRI/2025/02/080581 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomised controlled trial on adding Dapagliflozin to lupus nephritis treatment |
|
Scientific Title of Study
|
A comparison between standard of care treatment and Dapagliflozin added to standard of care treatment in maintenance phase of lupus nephritis patients a randomised controlled trial pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR YOGESH E KHANDAGALE |
| Designation |
Senior resident of Nephrology PGIMER |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology PGIMER Madhya Marg Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7066437608 |
| Fax |
|
| Email |
yogeshkhandagale19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANISH RATHI |
| Designation |
Professor of Nephrology PGIMER Chandigarh |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology PGIMER Madhya marg sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9216721287 |
| Fax |
|
| Email |
drmanishrathi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YOGESH E KHANDAGALE |
| Designation |
Senior Resident of Nephrology PGIMER |
| Affiliation |
PGIMER |
| Address |
Department of Nephrology PGIMER Madhya marg sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7066437608 |
| Fax |
|
| Email |
yogeshkhandagale19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology PGIMER Madhya Marg sector 12 Chandigarh India Pincode 160012 |
|
|
Primary Sponsor
|
| Name |
DR MANISH RATHI |
| Address |
Department of Nephrology PGIMER Madhya Marg sector 12 Chandigarh 160012 |
| 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 YOGESH E KHANDAGALE |
PGIMER Chandigarh |
Department of Nephrology PGIMER Madhya Marg sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH |
7066437608
yogeshkhandagale19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
Dapagliflozin 10mg once a daily will be given along with Standard Of Care treatment for 12 months |
| Comparator Agent |
Standard Of Care Treatment |
Maintenance therapy with Mycophenolate Mofetil 1-2gm per day Prednisolone 0.5 to 1 mg per day taperred over several months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed Lupus Nephritis with biopsy proven(Classes - III, IV, V, III +V, IV+V) are eligible if they are above 18 year of age |
|
| ExclusionCriteria |
| Details |
1.Patient having pulmonary alveolar haemorrhage
2.Patient with neuropsychiatric SLE
3.Patient with rapidly progressive renal failure
4.Patient who are on hemodialysis
5.Patient with eGFR less than 25ml per min per 1.73m2
6.Patient with baseline creatinine more than 3mg per dl
7.Patient unwilling to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment Response as per KDIGO guidelines, Serum Creatinine , 24hr urine protein |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frequency of urinary tract infection in both Arms,Number of Lupus flare in both Arm,
Number of SLE related complications & deaths in each Arms. |
Followed up after every monthly for 6 months & 3 monthly until 12 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/02/2025 |
| 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="6"
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
|
After getting the informed consent, the patients with Lupus Nephritis will be screened as per the inclusion and exclusion criteria . After fulfilment of the inclusion criteria, patient will be randomised into either arm. All patients in the both arm will be receiving maintenance therapy with Mycophenolate Mofetil 1 to 2 gm per day with oral prednisolone 0.5 to 1mg per kg per day tapered over several months. The treatment arm will receive Dapagliflozin 10mg per day in addition to Mycophenolate Mofetil and Steroids. The patients are followed up every monthly for first 6 months. At the end of first 6 month, response to therapy is assessed as per KDIGO guidelines. In addition to treatment responses screening of urinary tract infections, blood glucose levels, number of lupus flares during treatment will be assessed. Similarly patient will be evaluated every 3 months after the initial maintenance phase till 1 year. |