NCT01939977已完成4 期
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.
Fundación Senefro16 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 16
- 主要终点
- Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
研究概览
简要总结
To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
详细描述
The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
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
- None
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
- •Patient that have willingly signed and dated the ICD (Informed Consent Document) approved by the EC (Ethics Committee) before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
- •Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
- •24 hours previous to the transplantation, patient must have a significant grade of secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels between 110 and 600 pg/mL as per central laboratory results.
- •Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
- •Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
- •Patients that are to be treated with immunosuppression based on tacrolimus, mofetil mycofenolate or mycophenolic acid and with steroids and that are not going to be treated with mTOR (mammalian target of rapamycin) inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation.
- •Patients that are able to take oral capsules on the first week post-transplantation.
排除标准
- •Third or subsequent renal transplantation.
- •Positive cross-match assay or ABO (A-B-0) incompatibility
- •Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
- •Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
- •Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsorption.
- •Patient with hypo or hyperthyroidism not controlled based on investigators criteria.
- •Patient with uncontrolled hypertension based on investigators criteria.
- •Patients that, 48 hours previous to transplantation, have been receiving calcimimetics.
- •Patients with VIH (human immunodeficiency virus)infection of positive serology for HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
- •Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC)
- •Patients that are participating on other clinical trial with investigational drugs.
- •Women of childbearing potential (defined as those whose last menstruation was <2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment.
- •Patient with other diseases or conditions that based on investigators criteria are not suitable for the study.
- •Treatment will not be started if the Calcium-Phosphorus product (CAxP)is >55 mg2/dL2 or in case of hyperphosphatemia considered significant as per investigator criteria
研究组 & 干预措施
Paricalcitol
Experimental
Paricalcitol oral capsules.
干预措施: Paricalcitol (Drug)
Calcifediol
Active Comparator
Calcifediol oral drops.
干预措施: Calcifediol (Drug)
结局指标
主要结局
Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
时间窗: 6 months
Percentage of patients with iPTH serum concentration \>110 pg/mL 6 month after transplant.
次要结局
- Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.(6 months)
- Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group(6 months)
- Change on iPTH Serum Concentration. Intention to Treat Analysis.(6 months)
- Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.(6 months)
- Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.(6 month)
- Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.(6 months)
- Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.(6 months)
- Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.(Months 1, 3 and 6)
- Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.(Months 1, 3 and 6)
- Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.(6 months.)
- Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.(6 months)
- Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.(6 months)
- Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.(6 months)
- Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.(6 months)
- Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.(6 months)
研究者
研究点 (16)
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