NCT01128179已完成2 期
A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
研究概览
简要总结
To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting all of the criteria listed below may be included in the study:
- •≥18 years old.
- •Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
- •Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
- •Screening serum c-terminal FGF23 > 50.0RU/mL.
- •Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
- •Normal serum phosphate (0.808-1.55mmol/L).
- •Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
- •Adequate protein diet (includes 2-3 portions of protein-rich food per day).
- •An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- •Ability to provide written, signed, and dated (personally) informed consent to participate in the study.
- •Exclusion Criteria
- •Vitamin D supplementation required.
- •Compounds containing calcium, phosphate, aluminium or magnesium required.
- •Acute renal failure.
- •Rapidly progressing glomerulonephritis.
- •Vegetarian diet.
- •Known allergy to iodine.
- •Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
- •Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal).
- •Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
- •Life-threatening malignancy or current multiple myeloma.
- •Known to be Human Immunodeficiency Virus (HIV) positive.
- •History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
- •History of alcohol or other substance abuse within 6 months prior to screening.
- •Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
- •Subjects who have previously been enrolled into this study and subsequently withdrawn.
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Lanthanum carbonate
Experimental
干预措施: Lanthanum carbonate (Drug)
结局指标
主要结局
Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
时间窗: 12 Weeks
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
次要结局
- Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)(12 Weeks)
- Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)(12 weeks)
- Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)(12 weeks)
- Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)(12 weeks)
- Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)(12 weeks)
- Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)(12 weeks)
研究者
研究点 (1)
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