A clinical trial to determine if the test drug (Dapagliflozin) is better that placebo (Dummy drug) when used along with the standard therapy in patients with chronic kidney disease in reducing incidence of worsening of this condition.
- Conditions
- Chronic kidney disease, stage 2 (mild), Men and women ≥18 years of age with Chronic Kidney Disease.,
- Registration Number
- CTRI/2017/08/009535
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study to investigate whether dapagliflozin 10 mg versus placebo, given once daily, compared with placebo, reduces the incidence of the primary composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal deathwhen added to background standard of care treatment. The primary outcome will be 50% sustained\* decline in eGFR, reaching ESR, sustained eGFR <15 mL/min/1.73m2 or, chronic dialysis treatment or receiving a renal transplant, CV death and renal death. The study will be conducted in about 30 centres in India and globally around 20-25 countries. The sample size from India could be around 600 patients and 4000 patients from rest of the world. The duration of the study will be around 4 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 4000
- Provision of signed informed consent prior to any study specific procedures 2.
- Female or male aged ≥18 years at the time of consent 3.
- eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 4.
- UACR ≥200 and ≤5000 mg/g at visit 1 5.
- Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated.
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis 2.
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment 3.
- History of organ transplantation 4.
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor 5.
- Type 1 diabetes mellitus (T1D) 6.
- New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment (see Appendix C) 7.
- MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment 8.
- Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization 9.
- Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement 10.
- Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).
- Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment) 12.
- Known blood borne diseases such as specified in Appendix B (category A and B) 13.
- Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of more than 50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal death when added to current background therapy in patients with eGFR less than 25 and less than 75 ml/min/1.73m2 and albuminuria (urine albumin creatinine ratio [UACR] more than 200 and less than 5000 mg/g). 1. 50% sustained decline in eGFR | 2. Reaching ESRD | a. Sustained eGFR less than15 mL/min/1.73m2 or, | b. Chronic dialysis treatment or, | c. Receiving a renal transplant | 3. CV death | 4. Renal death
- Secondary Outcome Measures
Name Time Method To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoints of worsening of renal function. 1. more than 50% sustained decline in eGFR
Trial Locations
- Locations (20)
Ajanta Hospital and IVF Centre
🇮🇳Lucknow, UTTAR PRADESH, India
Arthur Asirvatham Hospital
🇮🇳Madurai, TAMIL NADU, India
B. J. Medical College & Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
CIMETS Inamdar Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Government Medical College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Government Medical College, Kozhikode
🇮🇳Kozhikode, KERALA, India
Govt. Stanley Medical College & Hospital
🇮🇳Chennai, TAMIL NADU, India
GSVM Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Institute of Post Graduate Medical Education & Research
🇮🇳Kolkata, WEST BENGAL, India
KG Hospital and Post Graduate Medical Institute
🇮🇳Coimbatore, TAMIL NADU, India
Scroll for more (10 remaining)Ajanta Hospital and IVF Centre🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Deepak DewanPrincipal investigatordrdeepakdewan@rediffmail.com