Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Tab.HRPT-091514: One capsule twice a day for 180 days as an
adjuvant therapy along with SOC for CKD management
Control Intervention1: Standard of Care: Subject will be standard of Care
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
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: 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. OR 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
Exclusion criteria: 1.CKD Stage G1 and G2, Stage G4 (eGFR and stage G5 (eGFR 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preservation /Improvement in the eGFR from baseline baseline to Day 90/180Timepoint: Day 90/180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in stage of CKD from baseline to Day 90/180 The improvement of Urine Albumin Creatinine Ratio (uACR) from baseline to Day 90/180 Improvement in clinical symptoms and QOL Incidence of drug related AE/SAETimepoint: Day 90/180 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
The Himalaya Drug Company
Outcome results
None listed