Randomized controlled trial to compare the efficacy of ferric citrate with sevelamer carbonate as phosphate binder in chronic kidney disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Hyperphosphataemia represents a significant challenge in the management of chronic kidney disease, exerting a pronounced influence on the pathogenesis of cardiovascular complications and mineral bone disorders. Hyperphosphataemia is defined by a serum level higher than 4.5 mg/dL or 1.78 mmol/L. Hyperphosphatemia occurs in CKD when reduced renal phosphate excretion and other homoeostatic mechanisms fail to eliminate excess phosphate. The inability to control serum phosphate level in chronic kidney disease (CKD) patients is a potentially life altering condition that can lead to cardiovascular calcification, metabolic bone disease (renal osteodystrophy) and the development of secondary hyperparathyroidism (SHPT).
This thesis will focus on contributing to understanding of the effect of Ferric citrate and Sevalamer carbonate on hyperphosphatemia in patients of Chronic Kidney disease.
Publications will be done using the data and results obtained during the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give written informed consent.
- •Age of 18 years or more.
- •Patients of any gender with current clinical diagnosis of Stage 3 CKD and above as per KDIGO guidelines.
- •Patients with no planned renal transplant during study period.
排除标准
- •Significant gastro-intestinal disorder (including, but not limited to known active peptic ulcer, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, GI motility disorder)
- •Current malignancy
- •Patients on treatment of osteoporosis
- •Patients on treatment of thiazide diuretics
- •Patients receiving Intravenous Iron Supplements.
- •Patients with history of renal calculus
- •Pregnant and lactating women
- •Known hypersensitivity to phosphate binders.
研究者
Mitali Gupta
Dr. Rajendra Prasad Medical College, Tanda