EUCTR2015-000619-42-ES进行中（未招募）1 期
An open, Phase II, clinical trial to evaluate the effectiveness of decreased intestinal absorption of phosphorus in the progression of renal disease in patients with metabolic syndrome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- FIBICO
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients who have previously participated in the study entitled Influence of phosphorus excretion on the progression of renal damage: Mechanisms and clinical studies and belonging to the group formed by tertile 2 + 3, according to the ratio between urinary excretion of phosphorus and creatinine (P / Cr).
- •2. Subjects of both sexes with age range between 18 and 85 years.
- •3. Patients with metabolic syndrome, defined by the presence of three or more of the diagnostic criteria established in the Joint Interim Statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity (Alberti et al Circulation 2009; 120:.. 1640-1645):
- •(1) high waist circumference (women ?88 cm, man ?102 cm)
- •(2) elevated triglycerides (?150 mg / dL) or use of specific medication
- •(3) reduced HDL (men <40 mg / dL, women <50 mg / dL) or use of specific medication
- •(4) impaired fasting glucose (?100 mg / dL) or use of antidiabetic medication
- •(5) hypertension (systolic blood pressure ?130 or diastolic ?85 mm Hg or respectively) or use of antihypertensive medication.
- •4. Glomerular filtration rate estimated by the formula CKD-EPI, between 30 and 90 ml / min / 1.73m2. (stages 2 and 3 of the classification of chronic kidney disease)
- •5. Patient able to understand the study procedures and granted their informed consent trial participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 99
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. hyperphosphataemic defined as phosphorus concentration greater than 5 mg / dl.
- •2. Patients with clinical signs of congestive heart failure.
- •3. Active infections within 30 days prior to baseline.
- •4. Patients with systemic inflammatory disease.
- •5. HIV infection, Hepatitis C and Hepatitis B.
- •6. History of cancer within the previous five years.
- •7. Chronic liver disease.
- •8. immunosuppressive therapy.
- •9. Pregnant women, breastfeeding, or planning to become pregnant.
- •10. Addiction to drugs or alcohol in the investigator's opinion, may interfere with the fulfillment of study requirements.
- •11. Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.
- •12. Changes 5% higher glomerular filtration regarding renal function available prior to inclusion in the study
研究者
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