EUCTR2008-006380-36-IT进行中（未招募）1 期
A PROSPECTIVE, PILOT, CROSS-OVER STUDY TO ASSESS THE EFFICACY OF PARICALCITOL IN REDUCING PARATHYROID HORMONE LEVELS AND AMELIORATING MARKERS OF BONE REMODELLING IN RENAL TRANSPLANT RECIPIENTS WITH SECONDARY HYPERPARATHYROIDISM (APPLE STUDY) - ND
IST. DI RICERCHE FARMACOLOG. M. NEGRI0 个研究点目标入组 42 人开始时间: 2008年11月6日最近更新:
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
- 入组人数
- 42
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
入选标准
- •- Males and females >18 years old; - Renal transplant recipients with persistent secondary hyperparathyroidism; - PTH persistently >80 pg/mL up 2 month post transplant (stable or progressively increasing PTH levels); - No ongoing therapy with Vitamin D; - Patients on maintenance therapy with calcineurin inhibitors and Mycophenolate Mofetil or Azathioprine; - Serum creatinine < 2mg/dL; - Patients legally able to give written informed consent to the trial (signed and dated by the patient); - Written informed consent.
- •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
- •- Concomitant administration of other forms of Vitamin D (different from paricalcitol ); - PTH< 80 pg/ml; - Serum Ca> 10,2 mg/dL - Clinically serious condition; - History of malignancy; - Evidence of active hepatitis C virus, hepatitis B virus or human acquired immunodeficiency virus infection; - Specific contraindications or history of hypersensitivity to the study drugs; - Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer; - Drug or alcohol abuse; - Any chronic clinical conditions that may affect completion of the trial or confound data interpretation; - Pregnancy or lactating; - Women of childbearing potential without following a scientifically accepted form of contraception; - Legal incapacity; - Evidence of an uncooperative attitude; - Any evidence that patient will not be able to complete the trial follow-up. - Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.
研究者
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