A Single Arm Trial in Treatment of CKD Patients with Sodium Copper Chlorophyllin Formulation

Abstract

In a prospective, single arm study of 34 Chronic Kidney Disease (CKD) patients in a trial of 90 days wherein patients got standard-of-care treatment and liquid composition containing Sodium Copper Chlorophyllin, the Investigational Product (IP), as add-on treatment for first 60 days and patients were ‘off’ the IP for last 30 days. Significant reduction in serum creatinine, Blood Urea and Uric acid level and significant improvement in estimated Glomerular Filtration Rate (eGFR), and Health related criteria for quality of life were observed in 60 days’ period of administration. eGFR remained significantly higher on 90th day than 0 day despite withdrawal of IP after 60 days. These observations suggest partial/limited reversal of lost kidney function as a lingering effect of the IP. Both these are first observations opening up new avenues for improving life of CKD patients. This is first clinical trial report of an orally consumed product that decreases serum creatinine and also actually improved health related quality of life within 60 days and a surprising evidence that suggests significant degree of restoration of kidney function in the progressively degenerative disease CKD. This clinical trial opens opportunities for managing CKD that were never available so far.