EUCTR2011-005017-37-NL进行中（未招募）不适用
A randomised, controlled clinical trial assessing the efficacy ofLanreotide to halt disease progression in ADPKD - The DIPAK 1 Study
DIPAK Consortium0 个研究点开始时间: 2012年5月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Diagnosis of ADPKD, based upon the modified Ravine criteria
- •2. Age between 18 and 60 years.
- •3. eGFR (MDRD) between 30 and 60 mL/min/1.73 m2.
- •4. Providing informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who, in the opinion of the study investigator may present a safety risk.
- •2. Patients who are unlikely to adequately comply with the trial’s procedures [due for instance to medical
- •conditions likely to require an extended interruption or discontinuation, history of substance abuse or
- •noncompliance).
- •3. Patients taking medications or having concomitant illnesses likely to confound endpoint assessments (e.g.
- •nephrotoxic medications such as chronic NSAID, cyclosporine, lithium immunosuppressant use, and e.g. diabetes
- •mellitus and patients with proteinuria > 1 g /24hr).
- •4. Patients who underwent surgical or drainage interventions for cystic kidney disease the year before study-entry
- •or are likely candidates for these procedures within 2 years of start of the study.
- •5. Patients taking other experimental (i.e., non marketed) therapies.
- •6. Patients having used Lanreotide (or another somatostatin analogue) in the 3 months before study start.
- •7. Patients known with intolerance for Lanreotide (or another somatostatin analogue).
- •8. Unwillingness to comply with reproductive precautions. Women who are capable of becoming pregnant must be
- •willing to comply with approved birth control from two-weeks prior to, and for 60 days after taking investigational
- •9. Women, who are pregnant or breastfeeding.
- •10. Patients, who suffer from cardiac arrhythmia’s, with the exception of stable atrial fibrillation.
- •11. Patients, who ever suffered from symptomatic gallstones, with the exception of patients who underwent a cholecystectomy.
- •12. Patients, who have a medical history of pancreatitis.
研究者
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