Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Ferronemia: Ferronemia 1 tab PO BID for 24 Weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Raj Kanwar Yadav
Eligibility
Inclusion criteria
Inclusion criteria: 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. Time to dialysis of at least 1 year as per investigatorâ??s judgement. Must be able to give voluntary written informed consent Females of childbearing potential must have negative serum pregnancy test at screening and agree to use adequate contraception throughout the study period
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate anti-inflammatory effect of FerronemiaTimepoint: 24 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in hemoglobin and eGFR rateTimepoint: 24 Week | — |
Countries
India
Contacts
Public ContactDr Raj Kanwar Yadav
All India Institute of Medical Sciences
Outcome results
None listed