EUCTR2009-011378-14-GR进行中（未招募）不适用
The IMPACT SHPT Study: Study to Evaluate the Improved Management of iPTH with Paricalcitol-centered Therapy vs. Cinacalcet Therapy with Low-dose Vitamin D in Hemodialysis Patients with Secondary Hyperparathyroidism - IMPACT SHPT
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 248
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
- •A patient will be eligible for study participation if he/she meets the following criteria:
- •1. Male or female patients = 18 years old.
- •2. Patient has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the
- •nature of the study has been explained and the patient has had the opportunity to
- •ask questions. The informed consent must be signed before any study-specific
- •procedures are performed or any medications are withheld.
- •3. Patient is diagnosed with Stage 5 CKD and has been receiving IV or oral vitamin
- •D receptor activators (VDRAs) for at least 8 weeks prior to the Screening Period
- •or naive patients that have not received VDRA therapy since the start of dialysis.
- •4. Patient is on maintenance HD (hemodialysis) TIW for at least 3 months prior to
- •screening and is expected to remain on HD for the duration of the study.
- •5. For entry into the Pre-Treatment Washout Period (for patients that are not naïve to VDRAs and cinacalcet), the patient must have screening laboratory values of:
- •? iPTH level 130 to 800 pg/mL
- •? Serum Total Alkaline Phosphatase level > 80 U/L
- •? Calcium level = 10.0 mg/dL (2.49 mmol/L)
- •? Ca×P = 75 mg2/dL2 (US) and = 70 mg2/dL2 (ex-US)
- •For entry into Treatment Period (for patients that have completed the washout or that are naïve to VDRAs and cinacalcet), the patient must meet the following laboratory criteria prior to randomization:
- •? iPTH between 300 and 800 pg/mL
- •? Calcium level of 8.4 to 10.0 mg/dL inclusive (2.09 to 2.49 mmol/L)
- •? Phosphorus = 6.5 mg/dL (2.09 mmol/L)
- •6. If female, patient is not breastfeeding.
- •7. If female, patient must have a negative serum pregnancy test prior to the
- •Treatment Period.
- •8. If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or is of childbearing potential and practicing one of the following methods of birth control:
- •? Maintains a monogamous relationship with a vasectomized partner.
- •? Double barrier method (any two of the following: condoms, contraceptive
- •sponge, diaphragm, vaginal ring with spermicidal jellies or creams or
- •intrauterine device [IUD]).
- •? Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to and during study drug administration.
- •? Total abstinence from sexual intercourse during the study (minimum one
- •complete menstrual cycle prior to study start).
- •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
- •A patient will be excluded from the study if he/she meets any of the following criteria:
- •1. Patient has a history of an allergic reaction or significant sensitivity to drugs
- •similar to the study drugs (paricalcitol, cinacalcet, doxercalciferol [IV sites], or
- •alfacalcidol [oral sites]).
- •2. Patient is expected to need more than 2.0 grams of oral elemental calcium per day
- •as total intake, which includes more than 1.5 grams of elemental calcium as the
- •phosphate binder.
- •3. Patient has a history of parathyroidectomy.
- •4. Patient has chronic gastrointestinal (GI) disease, which, in the opinion of the
- •investigator, may result in clinically significant gastrointestinal malabsorption.
- •5. Patient has a current malignancy (with the exception of basal or squamous cell
- •carcinoma of the skin), or clinically significant liver disease, in the opinion of the
- •investigator.
- •6. Patient has a history of drug or alcohol abuse that, in the opinion of the
- •investigator, is thought to impact the patient's participation in the study.
- •7. Patient has evidence of poor compliance with diet, medication or HD that may
- •interfere, in the opinion of the investigator, with adherence to the protocol.
- •8. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of
- •cytochrome P450 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6
- •(CYP2D6) (e.g., metoprolol, carvedilol, flecainide, vinblastine, thioridazine and
- •most tricyclic antidepressants) within 2 weeks prior to study drug administration.
- •9. Patient has participated in any investigational study or received any investigational drug within 4 weeks prior to the Treatment Period.
- •10. After entry into the Pre-Treatment Washout Period, patient is taking calcitonin,
- •maintenance IV or oral glucocorticoids (> 5 mg per day of prednisone or
- •equivalent), bisphosphonates, immunosuppressants or other drugs that may affect
- •calcium or bone metabolism, other than calcium and non-calcium containing
- •phosphate binders or females on stable estrogen and/or progestin therapy (same
- •dose and product for 3 months prior to study drug administration).
- •11. Patient is known to be HIV positive.
- •12. For any reason, subject is considered by the investigator to be an unsuitable
- •candidate to receive any of the study medications or is put at risk by study
- •procedures.
- •13. Patient has any of the known contraindications of cinacalcet.
研究者
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