Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
Intervention1: Renochlor Tablet 40 mg active Sodium Copper Chlorophyllin: 1 tablet of 40 mg active Sodium Copper Chlorophyllin, 3 times in a day (Oral route, for 90 days)
Control Intervention1: Renoch
Sponsors
Thinq Pharma CRO Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria: 1. Male or female subjects aged between 18-75 years (both inclusive). 2. Subject with clinically diagnosed with chronic kidney disease (CKD) (an eGFR of 30 to 60 ml/min/1.73 m2 3. Subject voluntarily provides written informed consent and comes for regular follow up.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if ANY of the following conditions apply: 1. Subjects with life expectancy less than one year 2. Subjects who have had renal replacement therapy in the prior 3 months 3. Subjects who had renal transplants or planning for renal transplantation during the study period 4. Evidence of recent acute kidney injury ( >50% increase in serum creatinine in the preceding 30 days) 5. Subjects on chronic dialysis therapy or had episode(s) of dialysis in the past 3 months 6. Subject having any disease/ abnormalities as follow, Cardiovascular system: 7. Subject with unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery and any clinically significant cardiac arrhythmias. 8. Subjects with known case of Secondary or Malignant Hypertension. 9. Subjects with known case of symptomatic congestive heart failure, severe aortic stenosis Endocrine system: 10. Subjects with uncontrolled Type 1 and Type 2 Diabetes Mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%. Hepatic system: 11. Subjects with abnormal Liver Function Test with values more than 3 times the upper limit of normal. 12. Female subjects who are pregnant, lactating or planning to become pregnant during the study period. 13. Subjects who is chronic smoker, alcoholic or drug abuse suspected. 14. Subjects with known case of HIV, Hepatitis B or C. 15. Subjects with medical history of oncological conditions since last 2 years. 16. Subjects who have participated in other clinical trials within 3 months prior to the screening examination. 17. Subject with hypersensitivity to any of the ingredients of the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of eGFRTimepoint: Day -3, Day 30, 60 and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Albumin-to-creatinine ratio (ACR)Timepoint: Day -3, Day 30, 60 and 90;Change in BUN and electrolytes as compared to baseline.Timepoint: Day -3, Day 30, 60 and 90;Change in Serum CreatinineTimepoint: Day -3, Day 30, 60 and 90;Change in TGF-β1 from baseline visit to end of study visitTimepoint: Day -3 and day 90;Incidence rates of AE/ SAE including changes in vital signs and laboratory parametersTimepoint: Day -3, Day 1, Day 30, 60 and 90;Kidney Disease Quality of Life (KDQOL-SFTM) Version 1.3Timepoint: Day -3 and Day 90 | — |
Countries
India
Contacts
Public ContactDr Milind Gharpure
Mediclin Clinical Research
Outcome results
None listed