EUCTR2007-001043-22-DE进行中（未招募）不适用
A Multicenter, Open-Label Study of Hectorol (doxercalciferol capsules) for the Treatment of Secondary Hyperparathyroidism in Stage 3 or Stage 4 Chronic Kidney Disease (CKD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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.Male or female, aged 18 years or older.
- •2.CKD Stage 3 or 4, defined as glomerular filtration rate (GFR) from the abbreviated Modification of Diet in Renal Disease (MDRD) equation between 30 and 59 mL/min/1.73m2 for CKD Stage 3 or between 15 and 29 mL/min/1.73m2 for CKD Stage 4 at the Screening Visit.
- •3.iPTH > 70 pg/mL (> 7.7 pmol/L) for CKD Stage 3 or > 110 pg/mL (> 12.1 pmol/L) for CKD Stage 4, but < 700 pg/mL (< 77 pmol/L) at Week –1.
- •4.In the opinion of the Investigator, the patient is willing and able to maintain compliance with phosphate binder therapy (if applicable) throughout the study duration.
- •5.Willing and able to stop any prior active vitamin D therapy (e.g. alfacalcidiol, calcitriol, or paricalcitol) and/or calcimimetic for 28 days prior to Week –1 and maintain this throughout the study.
- •6.Willing and able to sign and date an Informed Consent form.
- •7.The patient, if of childbearing potential, must be willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices.
- •8.A level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Intact PTH value > 700 pg/mL (> 77.0 pmol/L) at the Week -1 Visit.
- •2.Corrected serum calcium > 10.0 mg/dL (> 2.5 mmol/L) at Week –1.
- •3.Serum phosphorus > 5.0 mg/dL (> 1.61 mmol/L) at Week –1.
- •4.In the opinion of the Investigator, the patient currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any other clinically significant, unstable medical condition.
- •5.Abnormal liver function as measured by alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than three times the upper limit of normal at the Screening Visit.
- •6.Deemed by the Investigator to have rapidly deteriorating renal function.
- •7.Spot urine calcium/creatinine ratio > 0.2 at Week –1.
- •8.Current malabsorption, severe chronic diarrhea, or ileostomy.
- •9.Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion criterion.
- •10.Allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for hypersensitivity to vitamin D therapy.
- •11.Active ethanol or drug abuse, excluding tobacco use.
- •12.Current use of aluminum or magnesium based binders.
- •13.Pregnant or breast-feeding women.
- •14.Anticipated dialysis or planned renal transplant less than 12 months from Week 0.
- •15.Treatment with an investigational drug during 30 days preceding the start of screening.
- •16.Prior renal transplant.
研究者
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