2024-515542-16-03已完成4 期
Personalized Use of Resources Study (PURE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
研究概览
简要总结
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who receive tacrolimus who need a relatively high dose of tacrolimus, a C/D ratio < 1.05
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 years, inclusive, with a stable renal function; b. Patients who are at least 6 months until five years after first transplantation, who are not immunized (PRA<5%), with therapeutic tacrolimus concentrations between 4-9 ng/L, who are on a stable tacrolimus dose (same dosage of Tacrolimus extended release for the last month), with a C/D ratio < 1.05 ng/mL×1/mg; c. Patients must provide written informed consent; and d. Patients of childbearing potential must agree to use highly effective methods of contraception during the study.
排除标准
- •a. Patient received or is receiving treatment for acute rejection prior to initiation of study; b. Donor Specific antibody positivity and patients who are immunized (PRA≥5%); c. Chronic diarrhoea; d. Use of phenytoin, carbamazepine, phenobarbital, primidone, rifampin, caspofungin, erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole, fluoxetine, fluvoxamine, sertraline, venlafaxine, mirtazapine, paroxetine, diltiazem, verapamil, or amiodarone; e. Thyroid dysfunction; f. Excessive use of caffeine (more than use of 5 IE daily); g. Excessive use of alcohol (more than 2 IE daily); or h. Patients who are pregnant.
结局指标
主要结局
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who have a C/D ratio < 1.05 ng/mL×1/mg.
次要结局
- To evaluate if the switch design of the study leads to a lower pill burden; - to evaluate if the LCPT switch leads to less side effects; - to evaluate if the LCPT switch leads to less variability in trough levels; - to evaluate if patients with CYP3A5*1 allele is a factor to consider when prescribing tacrolimus variants; and - to evaluate differences in Cmax, Tmax and 24hour AUC levels.
研究者
drs Nienke Manson
Scientific
Stichting Amsterdam UMC
研究点 (1)
Loading locations...
相似试验
招募中
3 期
177Lu-edotreotide compared to everolimus in neuroendocrine tumors of the lung and thymus2022-502154-13-00Grupo Espanol De Tumores Neuroendocrinos135
招募中
3 期
A Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) plus BSC versus Placebo plus BSC in Participants with IPSS-R Low- or Intermediate-risk MDS2022-500479-29-00Celgene Corp.166
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
1 期
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor PatientsNCT07260305Kangabio AUSTRALIA LTD PTY57
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18