Health Condition 1: N289- Disorder of kidney and ureter, unspecified
Conditions
Interventions
None listed
Sponsors
Aimil Pharmaceuticals (India) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1)Participants of either sex aged 21 to 75 years 2)Participants with the diagnostic reports for nephritis, poor renal functions, and nephropathy. 3)Participants with Sr. creatinine (>= 1.35 mg/dL) and blood urea (>=24 mg/dL) levels above the normal range. 4)Individuals with stage I-IV CKD, with or without dialysis. 5)Willing to sign informed consent and comply with the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1)Participant with stage-V kidney failure 2)History of organ transplantation including renal transplantation 3)Individuals with mental disorders, severe infections, anaemia, and electrolyte imbalance, complicated or uncontrolled diabetes and hypertension 4)Subjects with active or past events of cerebral infarction, cerebral haemorrhage, myocardial infarction, unstable angina, heart failure or transient ischemic attack. 5)Impaired hepatic function with elevated SGOT and SGPT levels of 2.5 -fold the upper limit of normal level or above. 6)Severe edema, massive pleural or peritoneal effusion 7)Use of corticosteroids or immunosuppressive drugs in the previous 3 months 8)Allergy to the trial drugs 9)Participation in other clinical studies 10)Refuse to participate, or signed informed consent 11)Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Mean change in estimated glomerular filtration rate (eGFR) from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Urine albumin-to-creatinine ratio (UACR) from Visit 1 (screening) to Visit 4 [Duration: 120 days] Timepoint: Day -2, day 0, day 60, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Mean change in Sr. creatinine from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean change in blood urea nitrogen (BUN) from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean change in serum potassium (K) levels from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean change in urine albumin & urinary pH, from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean change in total serum protein from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Change in quality of life (QoL) evaluated using Short Form 36-item Health Survey (SF-36) from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean changes in the serum levels of SGPT and SGOT from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Mean changes in the CBC parameters from Visit 1 (screening) to Visit 4 [Duration: 120 days] â?¢Occurrences and frequencies of adverse and serious adverse events during the study period Timepoint: Day -2, day 0, day 60, Day 120 | — |
Countries
India
Contacts
Public ContactHasan Ali Ahmed
Xplora Clinical Research Services Pvt. Ltd
Outcome results
None listed