Title of Study: An Open-label, Randomized, Parallel-group, Two Arm Clinical Study to Evaluate anti-inflammatory effect of Ferronemia (lactoferrin and disodium guanosine monophosphate) tablet + Conservative Chronic Kidney Disease Management Therapy versus Conservative Chronic Kidney Disease Management Therapy in the Subjects with Chronic Kidney Disease. Study Phase: Investigator-Initiated Trial Objectives: To Evaluate anti-inflammatory effect of Ferronemia (lactoferrin and disodium guanosine monophosphate) tablet + Conservative Chronic Kidney Disease Management Therapy versus Conservative Chronic Kidney Disease Management Therapy in the Subjects with Chronic Kidney Disease. Design Prospective, Open Label, Randomized, Parallel-group, Two Arm Clinical Study in subjects with chronic kidney disease. Test Product Ferronemia (lactoferrin and disodium guanosine monophosphate) tablet + Conservative Chronic Kidney Disease Management Therapy Reference Product Conservative Chronic Kidney Disease Management Therapy Study Rationale Ferronemia tablet contains Lactoferrin and disodium guanosine monophosphate. Lactoferrin is a non-haem iron-binding protein that is part of the transferrin protein family and differs from transferrin by its higher affinity for iron which is 300 times greater and its ability to retain iron at a pH lower than 4 such as exist. (E.g. in the gastrointestinal tract or inflammatory lesions). Lactoferrin has antibacterial, antiviral, antioxidant, anti-inflammatory properties. Disodium Guanosine 5-Monophosphate is a salt of Guanosine 5-Monophosphate. Ribonucleoside Monophosphate which upon phosphorylation to GTP becomes incorporated into ribonucleic acid (RNAs) by various RNA polymerase(s). So, this study is planned to compare anti-inflammatory effect of Ferronemia (lactoferrin and disodium guanosine monophosphate) tablet + Conservative Chronic Kidney Disease Management Therapy with Conservative Chronic Kidney Disease Management Therapy. Dose and Mode of Administration Subjects enrolled in Arm A will receive Ferronemia tablet: Subjects will be instructed to take one tablet orally twice daily along with Conservative Chronic Kidney Disease Management Therapy as prescribed by the investigator. Subjects enrolled in Arm B will be instructed to take Conservative Chronic Kidney Disease Management Therapy as per the instructions of the investigator.
Population Subjects aged between 18 to 75 years (both inclusive) suffering from chronic kidney disease. Number of Subjects 40 subjects. Study Period Total study duration for the clinical part will be around 6 months that includes: Screening Period: Up to 4 weeks Treatment period – 6 months Inclusion Criteria: Subject participating in the study must meet the following criteria: 1. Male or female subjects aged 18 to 75 years (both inclusive) with Stage 1 (GFR >90 mL/min/1.73 m2), Stage 2 (GFR 60-89 mL/min/1.73 m2), Stage 3a (GFR 45-59 mL/min/1.73 m2), Stage 3b (GFR 30-44 mL/min/1.73 m2) or Stage 4 (GFR 15-29 ml/min/1.73 m2) chronic kidney disease for at least 3 months. 2. Time to dialysis of at least 1 year as per investigator’s judgement. 3. Must be able to give voluntary written informed consent 4. Females of childbearing potential must have negative serum pregnancy test at screening and agree to use adequate contraception throughout the study period Exclusion Criteria: 1) Patients currently receiving RRT or who will likely initiate RRT within 6 months. 2) History of hypersensitivity to /ferronemia or to any of the excipients of the study drug. 3) Poorly controlled diabetes mellitus as per investigator 4) Poorly controlled hypertension in spite of optimal medical management as per investigator. 5) Concomitant malignancy (except carcinoma in situ not needing other than local therapy and basal cell carcinoma of the skin) 6) Alcohol /drug dependence or abuse (excluding tobacco abuse) 7) Known history of positive HIV, HCV or HBsAg. 8) Pregnant or lactating females. 9) Abnormal ECG: QTc> 450 msec in male subject or QTc> 470 msec in female subjects at screening. 10) Having heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease 11) Liver cirrhosis 12) Cerebral infarction and intracranial hemorrhage within 6 months, except transient ischemic attack (TIA). 13) Severe anemia i.e. hemoglobin <9 g/dL 14) ALT or AST > 2.5 times the upper limit of normal. 15) Received immunosuppressive therapy (including systemic corticosteroids for more than 5 days at a daily dose in excess of 0.1 mg/kg, prednisolone equivalent) or agents such as tacrolimus, cyclosporine, Rituximab, mycophenolate or others (as per investigator) in the past 3 months, or anticipated to require such treatment during the study course. 16) Subjects who have been treated with an investigational drug within a period of 30 days prior to enrollment. 17) Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study. 18) Participation in any other clinical trial over the past 3 months Study Activities Outline: After obtaining the informed consent, subjects will be allowed to participate in the study related screening activities. Screening period is up to 4 weeks prior to randomisation. Day 1 will be the Randomisation visit. There will be one interim visit planned in the study on Week 12 (± 5 days). End of treatment visit will be performed on Week 24 (± 7 days). Key laboratory tests includes complete blood count, ESR, e- GFR and inflammatory marker assessment (IL-6,IL-10,TNF alpha,C-reactive protein). Laboratory Investigations Screening/Baseline: - Haematology (Complete blood picture including peripheral smear) - ESR - e-GFR - Inflammatory markers- IL6, IL10, TNF alpha, CRP - UPT During Study: week 12 - Haematology (Complete blood picture including peripheral smear) - ESR - e-GFR - Inflammatory markers- IL6,IL10,TNF alpha,CRP End of treatment: week 24 - Haematology (Complete blood picture including peripheral smear) - ESR - e-GFR - Inflammatory markers- IL6,IL10,TNF alpha,CRP Study Endpoints: Efficacy Endpoints: Primary Efficacy Endpoint: - Change in Inflammatory markers- IL6, IL10, TNF alpha, CRP Secondary Endpoints: Improvement in hemoglobin and eGFR rate Statistical Methods: Appropriate descriptive statistics and graphical displays for different types of data will be provided for analysis data set. |