Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Ferric citrate 1 g tablet (each tablet equals to 210 mg elemental iron): The subjects will receive study drug orally, three times daily with meals for 4 weeks (i.e. from Day 1 to Day 28
Sponsors
Mylan Laboratories Limited
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant, non-lactating female participants aged greater than 18 and less than 65 years with stage 3-5 chronic kidney disease not on dialysis (CKD-NDD) 2. Individuals will be considered suitable for treatment with ferric citrate based on Investigators clinical judgement. 3. Individuals with estimated glomerular filtration rate (eGFR) less than 60 mL/min, with Hb =9.0 g/dL and =12 g/dL, serum ferritin =300 ng/mL and percentage transferrin saturation (TSAT) =30 percentage at screening. 4. Individuals with body weight =50 kg at screening and randomization visit with body mass index (BMI) of 18.5 - 30.0 kg/m2 at the time of screening. 5. Individuals with adequate hematopoietic and liver function tests at screening as per Investigators judgement. 6. Female individuals should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral oophorectomy; or practicing an acceptable form of birth control
Exclusion criteria
Exclusion criteria: 1. Serum phosphorus level at screening less than 3.5 mg/dL. 2. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to screening. 3. Acute renal insufficiency or requirement for dialysis within 12 weeks prior to randomization. 4. Blood transfusion or intravenous (IV) iron administration or ESA administration within 4 weeks prior to screening. 5. Infection requiring oral or IV antibiotic use within 2 weeks prior to randomization. 6. Anemia other than iron deficiency or chronic kidney disease (CKD). 7. Known allergic reactions to oral or IV iron treatment or any of the excipients. 8. Liver enzymes [aspartate aminotransferase (AST) or alanine aminotransferase (ALT)] greater than 3 times upper limit normal (ULN) at Screening. 9. History of iron overload syndromes, such as hemochromatosis. 10. Previous intolerance to oral ferric citrate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with treatment success [where success is defined as an increase in Hb of =1.0 g/dL from baseline at the end of Week 4 (after 28 days of treatment)]. Timepoint: Day 1 to Day 29 + 2 days [End of Study (EOS)] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in serum ferritin from baseline to Week 4 (after 28 days of treatment) a. Mean change in Percentage transferrin saturation (TSAT) from baseline to Week 4 (after 28 days of treatment) b. Incidence of adverse events throughout the study. Timepoint: Safety will be assessed throughout the study, i.e., from Day 1 to Day 43 ±3 days [End of Study (EOS)] | — |
Countries
India
Contacts
Public ContactMr Hitesh Maheshwari
Cliantha Research Limited
Outcome results
None listed