A Randomized, multicenter, double-blind, parallel-group, three-arm, placebo-controlled study to evaluate the bioequivalence with the clinical endpoint of ferric citrate tablet of Mylan Inc versus Auryxia® (ferric citrate tablet, Keryx Biopharmaceuticals Inc) in patients with chronic kidney disease not on dialysis (CKD-NDD).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 423
- 试验地点
- 23
- 主要终点
- 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)].
研究概览
简要总结
This is a Randomized, multicenter, double-blind, parallel-group, three-arm, placebo-controlled study to evaluate the bioequivalence with the clinical endpoint of ferric citrate tablet of Mylan Inc. versus Auryxia® (ferric citrate tablet, Keryx Biopharmaceuticals Inc.) in patients with chronic kidney disease not on dialysis (CKD-NDD)
Participants will be enrolled in the study after successfully completing screening activities between Day -14 to Day -1. Approximately 423 participants with CKD-NDD fulfilling the eligibility criteria will be randomized in 1:1:1 ratio to receive either Mylan’s Ferric citrate tablet (n = 141), RLD - Auryxia ferric citrate tablet (n = 141) or Placebo (n = 141). Randomized participants will be treated with ferric citrate 1 g tablet (each tablet = 210 mg elemental iron) or Placebo, three times daily with meals for 28 days
Following laboratory assessments will be performed during Visit 1 (Screening Visit), Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6. Laboratory assessments done during Screening Visit will be considered for the purpose of determination of eligibility
· 1 Complete blood count- hemoglobin (Hb), hematocrit, total and differential white blood count (WBC), red blood count (RBC), platelet count
· 2 Complete chemistry profile including liver function tests (albumin, bilirubin, alanine aminotransferase
· 3 (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), serum creatinine,
· 4 Iron parameters - serum iron, serum ferritin, % transferrin saturation (TSAT), total iron binding capacity (TIBC), unsaturated iron-binding capacity (UIBC)
· 5 Urine analysis
· 6 Serum electrolyte
7 serum phosphorus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •Individuals will be considered suitable for treatment with ferric citrate based on Investigators clinical judgement.
- •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.
- •Individuals with body weight ≥50 kg at screening and randomization visit with body mass index (BMI) of 18.
- •30.0 kg/m2 at the time of screening.
- •Individuals with adequate hematopoietic and liver function tests at screening as per Investigators judgement.
- •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.
排除标准
- •Serum phosphorus level at screening less than 3.5 mg/dL.
- •Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to screening.
- •Acute renal insufficiency or requirement for dialysis within 12 weeks prior to randomization.
- •Blood transfusion or intravenous (IV) iron administration or ESA administration within 4 weeks prior to screening.
- •Infection requiring oral or IV antibiotic use within 2 weeks prior to randomization.
- •Anemia other than iron deficiency or chronic kidney disease (CKD).
- •Known allergic reactions to oral or IV iron treatment or any of the excipients.
- •Liver enzymes [aspartate aminotransferase (AST) or alanine aminotransferase (ALT)] greater than 3 times upper limit normal (ULN) at Screening.
- •History of iron overload syndromes, such as hemochromatosis.
- •Previous intolerance to oral ferric citrate.
结局指标
主要结局
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)].
时间窗: Day 1 to Day 29 + 2 days [End of Study (EOS)]
次要结局
- 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))
研究者
Dr Dharmesh Domadia
Cliantha Research Limited