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临床试验/NCT05029310
NCT05029310已完成4 期

Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年9月1日最近更新:
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
13
试验地点
1
主要终点
study potential interaction between patiromer and tacrolimus

研究概览

简要总结

Patiromer lowers potassium effectively in patients with hyperkalemia and chronic kidney disease. Patients with a kidney transplant usually have reduced renal function and may also develop hyperkalemia. However, potential interactions between immunosuppressive medications and patiromer have not been evaluated. These interactions could involve change in AUC of immunosuppressive drugs, such as calcineurin inhibitors or mycophenolate, or increased risk of hypomagnesemia, since both tacrolimus and patiromer have this potential side effect. We wish to evaluate potential interactions to ensure safe use of this drug in the transplant population.

详细描述

Patients with a kidney transplant may develop hyperkalemia. This could be due to different mechanisms. In some patients it could be due to reduced kidney function. In others, it could be secondary to renal tubular acidosis type 4 caused by necessary medications used after transplantation.

The most important medicines contributing to hyperkalemia after kidney transplantation are calcineurin inhibitors which are a compulsory part of the immunosuppressive regimen, ACE inhibitors or ARBs in patients with hypertension, and trimethoprim-sulfa, which is used as infection prophylaxis in all patients during the first 6 months after transplantation. In the weeks after renal transplantation around 5-10% of transplant patients at our institution at some point develop hyperkalemia above the limit where some type of management of hyperkalemia would be indicated. As the drugs mentioned above can rarely or not at all be withdrawn after transplantation, most doctors will either observe the hyperkalemia untreated or try to lower the potassium level.

In outpatients with s-potassium of 5 - 6.5, urgent management is usually not necessary. However, some kind of intervention is still indicated, to make sure that the potassium will decrease during the next days. Patiromer could be an interesting alternative in those kidney transplanted patients that are in this category. We are not aware of any published studies describing the use of patiromer in the transplant population. We intend to investigate if there is any pharmacokinetic interaction between patiromer and immunosuppressive drugs affecting the blood concentration of the latter.

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

入选标准

  • Renal transplant recipients, at least 3 weeks after transplantation, who receive Tacrolimus as part of their immunosuppressive therapy, with stabile tacrolimus dose and trough tacrolimus concentration.
  • Recipients 18 years of age or older.
  • Hyperkalemia (K>5 and <6,0)
  • Signed informed consent.

排除标准

  • Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, resonium-calcium, and/or sodium zirconium cyclosilicate.
  • Constipation, defined as fewer than three bowel movements per week.
  • Hypomagnesemia less than 0.6 mmol/L.
  • Serum potassium level of greater than 6.0 mEq/L.
  • Increased immunologic risk patient (DSA, ABO-incompatible transplant).
  • Pregnancy or suspected pregnancy (pregnancy is excluded at time of transplantation by measuring HCG, kidney transplanted patients should not become pregnant before at least one year after transplant, and no transplanted patient has ever become pregnant during the first weeks after transplantation. They are all informed regarding different types of contraception). Fertile women will be tested for pregnancy before inclusion.
  • Hypersensitivity/allergy to patiromer.
  • Other serious medical or psychiatric condition likely to interfere with participation.

研究组 & 干预措施

All patients use both patiromer and tacrolimus

Experimental

Pharmacokinetic investigation of tacrolimus performed in both the presence and absence of patiromer for all patients.

干预措施: Patiromer Oral Product (Drug)

结局指标

主要结局

study potential interaction between patiromer and tacrolimus

时间窗: two weeks

Log-transformed AUC0-tau of tacrolimus between patiromer vs. no patiromer

次要结局

  • Determine effect of patiromer on potassium concentration.(two weeks)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Geir Mjøen

Resident

Oslo University Hospital

研究点 (1)

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