Investigating the effect and safety of NEERI KFT on impaired kidney functions and as an adjuvant with Nephrotoxic drugs
- Conditions
- Health Condition 1: N289- Disorder of kidney and ureter, unspecified
- Registration Number
- CTRI/2023/07/054728
- Lead Sponsor
- Aimil Pharmaceuticals (India) Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Mean change in estimated glomerular filtration rate (eGFR) from Visit 1 (screening) to Visit 4 [Duration: 120 days] <br/ ><br>â?¢Urine albumin-to-creatinine ratio (UACR) from Visit 1 (screening) to Visit 4 [Duration: 120 days] <br/ ><br>Timepoint: Day -2, day 0, day 60, Day 120
- Secondary Outcome Measures
Name Time Method