A Clinical Study to Evaluate the Anti-inflammatory Effect of Lactoferrin + Disodium Guanosine Monophosphate Therapy in the Patients with Chronic Kidney Disease.

Abstract

Introduction: India is impacted by the increasing burden of chronic kidney disease (CKD) and end-stage renal disease (ESRD), necessitating efficient management and therapy. CKD is characterized by elevated levels of inflammatory biomarkers, specifically IL-1β, IL-1RA, IL-6, TNF-α, TGF-β, and fibrinogen. The aim of this research is to determine the antiinflammatory effects of lactoferrin + disodium guanosine monophosphate therapy in CKD patients. The objective of this study is to examine the efficacy of this therapy versus conservative CKD management alone in reducing inflammation. This study intends to examine the possible benefits of study drug in treating inflammation associated with CKD by analyzing its effect on inflammatory markers including IL-6 and TNF-α.

Methods: This randomized, open-label, parallel group, two-arm clinical study, comprising of 40 patients with CKD, with 20 patients in each group. The groups were well-matched in terms of demographic characteristics. Conception, screening, randomization, and follow-up visits including physical examinations, laboratory investigations, and medication dispensation were all carried out over a 29-week period. Creatinine clearance, estimated glomerular filtration rate (eGFR), estimated urine urea nitrogen, and inflammatory markers (IL-6, IL-10, TNF-α, CRP) were analyzed at time of screening and at 3 and 6-month postrandomization.

Results: The study found a significant decrease in inflammatory markers, including TNF-α, IL-6, and IL-10, in the group receiving study drug, indicating its potential as an antiinflammatory intervention for managing CKD. Secondary endpoints, including hemoglobin (Hb) and e-GFR levels, showed nonsignificant improvements in the study group compared to the control group. No significant adverse events were reported during the study.

Conclusion: The study highlights the potential antiinflammatory effects of the lactoferrin + disodium guanosine monophosphate therapy in individuals with CKD. The findings suggest that study drug may be a viable intervention for managing inflammation in CKD patients. Further research is needed to validate these results and explore its long-term effects in CKD management.