Role and effect of Capsule HRPT-091514 as an add treatment to normal standard treatment in patient with chronic kidney disease.

Phase 2

Recruiting

Conditions: Health Condition 1: N189- Chronic kidney disease, unspecified

Registration Number: CTRI/2020/12/029519

Lead Sponsor: The Himalaya Drug Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

AND

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preservation /Improvement in the eGFR from baseline baseline to Day <br/ ><br>90/180Timepoint: Day 90/180

Secondary Outcome Measures

Name	Time	Method
Improvement in stage of CKD from baseline to Day 90/180 <br/ ><br>The improvement of Urine Albumin Creatinine Ratio (uACR) from <br/ ><br>baseline to Day 90/180 <br/ ><br>Improvement in clinical symptoms and QOL <br/ ><br>Incidence of drug related AE/SAETimepoint: Day 90/180