A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)
研究概览
简要总结
Hyperparathyroidism (HPT) is common in people with a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have large parathyroid glands in the neck. Patients with HPT can develop bone disease (osteodystrophy). This bone disease can cause bone pain, fractures, and poor formation of red blood cells. Other problems from HPT may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). The high calcium levels may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems or kidney transplant dysfunction (worsening of kidney transplant function). The purpose of this study is to evaluate the effects of cinacalcet (Sensipar/Mimpara) on high calcium levels in the blood in patients with HPT after a kidney transplant.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Received a kidney transplant ≥ 9 weeks at time of Screening and ≤ 24 months before first dose
- •May be the first kidney transplant or a repeat kidney transplant.
- •Subjects with a functional, stable kidney transplant, defined as MDRD estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² (chromic kidney disease stage 3 or better) at Screening.
- •Men or women ≥ 18 years at the start of Screening (ie, time of informed consent).
- •Corrected total serum calcium > 10.5 mg/dL (2.63 mmol/L), defined as the mean of 2 values in Screening period.
- •iPTH > 100 pg/mL (10.6 pmol/L), during the Screening period (obtained at either Screen 1 or Screen 2).
排除标准
- •Received cinacalcet therapy post-transplant for more than 14 days cumulatively post-transplant. If cinacalcet therapy was received for a total of 14 days or less post-transplant, there must be a 4-week washout before subject is eligible for screening (Note: This does not exclude pre-transplant use of cinacalcet).
- •Anticipated parathyroidectomy within 6 to12 months after Randomization.
- •Ongoing therapy with bisphosphonates or use within 6 months prior to Screening.
- •Ongoing use of 1,25-dihydroxyvitamin D3 (including other active vitamin D metabolites or analogues) or use within 30 days prior to Screening.
- •Ongoing use of calcium supplements or use within 30 days prior to Screening.
- •Ongoing use of phosphate binders (calcium or non-calcium containing) or use within 30 days prior to Screening.
- •Ongoing use of a thiazide diuretic.
- •Subjects with a history of seizures who had a seizure within the 3 months prior to Randomization, which required adjustments to the seizure medication.
- •Acute Kidney Injury (AKI) or renal biopsy within 6 weeks prior to Screening, unless it is an institutional protocol-driven biopsy.
研究组 & 干预措施
Cinacalcet
Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parthyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
干预措施: Cinacalcet (Drug)
Placebo
Participants received placebo orally once daily for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With a Mean Corrected Total Serum Calcium Value < 10.2 mg/dL (2.55 mmol/L) During the Efficacy Assessment Phase (EAP)
时间窗: Weeks 21 to 26 (EAP)
次要结局
- Percent Change From Baseline to Week 52 in Bone Mineral Density at the Femoral Neck(Baseline and Week 52)
- Change From Baseline to the EAP in Mean Serum Phosphorus(Baseline and the EAP (mean of Weeks 22, 24, and 26))
- Change From Baseline to Week 52 in eGFR(Baseline and Week 52)
- Change From Baseline to the EAP in Corrected Total Calcium(Baseline and the EAP (mean of Weeks 22, 24, and 26))
- Change From Baseline to the EAP in Intact Parathyroid Hormone (iPTH)(Baseline and the EAP (mean of Weeks 22, 24, and 26))
- Change From Baseline to the EAP in Urine Phosphorus(Baseline and the EAP (mean of Weeks 22, 24, and 26))
- Percentage of Participants With a Parathyroidectomy(56 weeks)
- Time to Parathyroidectomy(56 weeks)