A multicentric, randomized, prospective, double blind, parallel group, comparative, active controlled, phase III clinical study to evaluate the efficacy, safety and tolerability of Fixed Dose Combination of Dapagliflozin 10 mg and Telmisartan 80 mg versus concurrent use Dapagliflozin 10mg tablets and Telmisartan 80mg tablets in patients with Chronic Kidney Disease.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 20
- 主要终点
- Changes in UACR
研究概览
简要总结
CKD is an important contributor to illness and is associated with a diminished quality of life and a reduced life expectancy. Despite the widespread availability of simple laboratory tests to identify patients with impaired kidney function, fewer clinical trials have been conducted for kidney diseases than for other common medical conditions.2 Until recently, the only classes of medication that have been shown to slow a decline in kidney function were angiotensin-converting–enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs); however, most of the evidence was generated in patients with type 2 diabetes.
Dapagliflozin and Telmisartan not only reduces blood sugar levels and hypertension respectively but also helps in reducing the symptoms of chronic kidney disease. Dapagliflozin shows natriuretic effects and telmisartan together with causing vasodilation have anti-proteinuric effect. USFDA and global regulatory agencies have approved Dapagliflizin 10mg for the treatment of Chronic Kidney Disease. ARB’s are first line recommendation for management of CKD related changed in microalbuminuria and eGFR over long-term alongwith other recommended pharmoctherapy drugs including SGLT2. The FSC of Dapagliflozin 10mg + Telmisartan 80mg will help to reduce the pil burden of CKD patients and improve dose adherence and patient compliance to study medication by reducing the number of tablets required daily.
The proposed study aims to evaluate the efficacy, safety and tolerability of fixed dose combination of Dapagliflozin and Telmisartan in chronic kidney disease in Indian patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to give consent to participate
- •Female or male aged 18-65 (both inclusive) years at the time of consent.
- •Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test.
- •UACR more than 200 and less than 5000 mg/g at visit
- •eGFR greater than 25 and less than 75 mL/min/1.73m2 (CKD-EPI Formula) at visit
- •Stable, and patient with maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated.
排除标准
- •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.
- •Type 1 diabetes mellitus (T1D).
- •New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment.
- •MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
- •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.
- •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 investigators clinical judgement.
- •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 more than 3x the upper limit of normal ULN, or total bilirubin more than 2x ULN at time of enrolment).
- •Known blood-borne diseases.
- •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.
- •Participation in another clinical study with an IP during the last month prior to enrolment.
- •Inability of the patient, in the opinion of the investigator, to understand and or comply with IP, procedures and or followup OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
结局指标
主要结局
Changes in UACR
时间窗: Day 180
次要结局
- Changes in UACR(Baseline at Day 45, 90 and 135)
- Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 30% decline in eGFR(Baseline, Day 90 and 180)
- Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 40% decline in eGFR(Baseline, Day 90 and 180)
- Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 50% decline in eGFR(Baseline, Day 90 and 180)
- Proportion of patients with reduction of the incidence of patients reaching CKD 4(Day 90 and 180)
- Proportion of patients with doubling of serum creatinine (compared to the most recent central laboratory measurement)(Day 45, 90 and 135)
- Changes in HbA1c(Baseline, Day 90 and 180)
- Change in systolic BP from(Baseline, Day 45, 90, 135 and 180)
- Change from baseline in the overall summary score of the KDQOL-36(Baseline, Day 45, 90, 135 and 180)
- Proportion of patients with either of Renal death, CV death or Hospitalization for heart failure(Day 180)
- All-cause mortality(Day 180)
研究者
Mr Kartik Sahni
Insignia Clinical Services Pvt. Ltd.