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临床试验/NCT02683889
NCT02683889已完成3 期

The Use of Acthar (ACTH) in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Have Developed Chronic Kidney Disease Stage V (CKD) or End Stage Renal Disease (ESRD) and Are Undergoing a Renal Transplant

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
15
试验地点
1
主要终点
Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria

研究概览

简要总结

This study will evaluate the use of Acthar in patients to undergo renal transplantation and will measure the rate of FSGS recurrence.

详细描述

This is a prospective study enrolling renal transplant recipients with the primary native kidney disease of FSGS.

Primary endpoint is rate of recurrence of FSGS as seen in renal transplant biopsies and in rate of proteinuria. Secondary endpoint is renal function after transplantation The target subject number is 20 patients and the target population is primary FSGS patients. By the current data, FSGS should recur in 23% of patients. Therefore, it would be expected that at least 4 patients will develop recurrent FSGS after renal transplantation.

Screening will be performed by the Principal Investigator during the kidney transplant evaluation clinics and during the wait list kidney transplant evaluation clinic. All patients with FSGS will have maintenance immunosuppression with belatacept (if EBV positive), prograf, cellcept and prednisone. If after one year the patient has been stable and there has not been rejection, will stop the prograf and continue solely with belatacept, cellcept and prednisone.

Dosage and Administration of Acthar The dose of acthar to be given to every enrolled patient will be 80 units twice a week for 6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To receive either a live donor or deceased donor kidney transplant

排除标准

  • Not having FSGS

研究组 & 干预措施

One arm

Experimental

One arm will receive acthar to measure rate of recurrence of FSGS after transplant. There are no other arms. We do have previous data that FSGS recurs in 23% of kidney transplants.

干预措施: Acthar (Drug)

结局指标

主要结局

Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria

时间窗: 2 years

This will be studied in the renal transplant biopsies

Rate of Recurrence of Proteinuria

时间窗: 2 years

By measurement of urine protein and urine creatinine ratio

次要结局

  • Renal Function After Transplantation(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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