Pharmacokinetic Study of Tacrolimus and Mycophenolate Mofetil in Kidney Transplant Recipients With Hyperkalemia Receiving Patiromer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
Hyperkalemia (high potassium in blood) is a common condition found in kidney transplant patients. Risk factors include poor kidney function and exposure to various drugs. Regardless of the causes, current treatment options are limited. Previously, the only available potassium binder for lowering potassium in the blood is sodium polystyrene sulfonate, which has unknown drug interaction profile with transplant medications. Patiromer is a newly approved potassium binder indicated for the treatment of hyperkalemia. Kidney transplant patients with hyperkalemia may benefit from patiromer. However, the interaction of patiromer and transplant medications has not been studied. The goal of this study is to look into the drug interactions between patiromer and transplant medications.
详细描述
This is an open-label single center pharmacokinetic study of kidney transplant recipients with hyperkalemia receiving tacrolimus and MMF-based immunosuppression.
Subjects will be screened for inclusion and exclusion criteria during the screening visit. There will be 2 study visits (visit 0 and visit 1) for each subject after successful screening. Visit 0 occurs within 14 days (± 3 days) after screening. Visit 1 occurs at 7 days (± 3 days) after visit 0. There will be 3 clinical visits (standard of care) after visit 1. A total of 6 visits are anticipated for this study.
Standard diet for lunch and dinner will be provided to subjects during visit 0 and visit 1. Meals provided will be monitored in relationship to C0 and C12.
During screening visit, blood tests for baseline BMP, aldosterone, magnesium, tacrolimus, DSA, and MMF will be obtained. If applicable, concomitant fludrocortiosone will be stopped prior to screening.
During visit 0, tacrolimus levels will be drawn immediately before (0 hr) and at 8 intervals after dosing (1,2,3,4,5,6,9,12 hrs). MMF levels will be drawn immediately before (0 hr) and at 9 intervals after dosing (1,2,3,4,5,6,7,9,12 hrs). Basic metabolic profile and serum magnesium levels will be drawn immediately before tacrolimus dosing. Oral MMF and tacrolimus will be dosed at 8am ± 1hr.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female, 18 years of age or older.
- •Patient is capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- •Kidney transplant recipient.
- •Must be receiving MMF for maintenance immunosuppression
- •Must be receiving tacrolimus for maintenance immunosuppression
- •Subjects must have hyperkalemia (serum potassium ≥ 5.0 mEq/L and ≤ 6.0 mEq/L).
- •Prior to enrollment, subjects must be taking a steady dose of tacrolimus for 3 days.
排除标准
- •Use of Kayexalate 1 day prior to screening visit.
- •Serum potassium level of greater than 6.0 mEq/L at screening.
- •Serum magnesium level of less than 1.0mg/dL at screening.
- •Acute rejection episode within 30 days prior to enrollment.
- •Anemia with hemoglobin level of ≤ 9.0 g/dL prior to screening.
- •Patient has hypersensitivity to patiromer.
- •Receiving maintenance corticosteroid for immunosuppression
- •Serious medical (including history of cardiac arrhythmias) or psychiatric illness likely to interfere with participation in this clinical study.
- •Patients with known donor-specific antibodies.
研究组 & 干预措施
Patiromer
干预措施: Patiromer (Drug)
结局指标
主要结局
AUC
时间窗: Within 30 days
Investigate the pharmacokinetics of tacrolimus and mycophenolate mofetil in kidney transplant recipients receiving patiromer. Investigators will obtain serum levels of tacrolimus and mycophenolate mofetil before and after the administration of the study drug patiromer. Investigators will measure the areas under the curve of tacrolimus and mycophenolate mofetil before and after exposure to patiromer.
次要结局
- Serum potassium levels(Within 30 days)