A randomized, open label, two arm, multicenter, prospective, clinicalstudy to evaluate efficacy and safety of HRPT-091514 as an adjuvantto standard of care in subjects with chronic kidney disease. - HRPT-091514

The Himalaya Drug Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

暂无简介。

•1.Subjects diagnosed with CKD (stage G3a, G3b, G4) due to diabetic nephropathy or hypertensive nephropathy
•Stage G3a (45-59 mL/min /1.73 m2)
•Stage G3b (30-44 mL/min /1.73 m2)
•Stage G4 (>= 21-29 mL/min /1.73 m2)
•Subjects with history of hypertension prior to onset of CKD
•uACR Stage A1: <30 mg/g OR uACR Stage A2: 30 300 mg/g
•2.uACR and eGFR stages stable for last 3 months.
•3.Subjects with stable medication for CKD for past 3 months (with ACE inhibitors / ARBâ??s along with diabetic/hypertensive medication, if they are on these medications).
•4.Women of non-child bearing potential.
•Men / Women willing to adhere to natural family planning methods/established contraceptive method, which are accepted ethical according to institutional policy.
•5.Willing to sign informed consent document and comply with study procedures.

•1.CKD Stage G1 and G2, Stage G4 (eGFR <= 20 ml/min/1.73m2)
•and stage G5 (eGFR <15 ml/min/1.73m2) of CKD subjects
•2.Macro albuminuria uACR >300 mg/g.
•3.CKD due to any other etiology like Glomerulonephritis, Interstitial nephritis, Pyelonephritis, Polycystic kidney disease,
•Prolonged obstruction of the urinary tract, Vesicoureteral reflux, analgesic nephropathy, nephrotic syndrome, glomerular disease, tubulointerstitial disease or any other renal pathology/disease. Pericarditis, pleuritis, Progressive uremic encephalopathy or neuropathy, with signs such as confusion, asterixis, myoclonus, and seizures, a clinically significant bleeding diathesis.
•4.Severe CKD which require hemodialysis, peritoneal dialysis, or kidney transplant within 3 months of screening.
•5.Acute kidney disease (acute kidney injury), Metabolic acidosis
•6.Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months of screening.

发起方