EUCTR2017-004701-40-IT进行中（未招募）1 期
A PILOT, PHASE II STUDY WITH A PROSPECTIVE, RANDOMIZED, CROSS-OVER, PLACEBO-CONTROLLED, DOUBLE-BLIND DESIGN TO ASSESS THE SHORT-TERM EFFECTS OF TOLVAPTAN PLUS PLACEBO VS TOLVAPTAN PLUS OCTREOTIDE LAR COMBINATION THERAPY IN ADPKD PATIENTS WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATION - Tolvaptan-Octreotide combination in ADPKD
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 20 人开始时间: 2019年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
入选标准
- •1. Adult (>18-yr-old) men and women, with a clinical and ultrasonographic diagnosis of ADPKD;
- •2. Serum creatinine < 1.0 mg/dl (for man) and < 1.2 mg/dl (for woman) and changes in serum creatinine (and creatinine clearance when available) <30% over the last six months;
- •3. Creatinine clearance > 80 ml/min/1.73m2 measured one to two weeks apart during the pre-screening period;
- •4. GFR = 80 ml/min/1.73m2 (by iohexol plasma clearance technique) at screening and baseline evaluations;
- •5. TKV ranging between 1000 and 2000 ml at screening (by ultrasound imaging) and at baseline (by MRI) evaluations;
- •6. Female participants must be of non-childbearing potential or must agree to abstinence or use a highly effective form of contraception;
- •7. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Patients with concomitant systemic, renal parenchymal or urinary tract disease;
- •2.Diabetes;
- •3.Overt proteinuria (urinary protein excretion rate >1 g/24 hours);
- •4.Abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease, urinary tract lithiasis, infection or obstruction, biliary tract lithiasis or obstruction;
- •5.Hemorrhagic or complicated cysts which might acutely affect kidney function and volumes;
- •6.QT-related ECG abnormalities;
- •7.Cancer and major systemic diseases that could prevent completion of the planned follow-up or interfere with data collection or interpretation;
- •8.Hypersensitivity to the IMP active substance or to any of the excipients or to benzazepine or benzazepine derivatives;
- •9.Concomitant treatment with drugs that may affect glomerular hemodynamics during the three months before the beginning of the study (including ACE inhibitors, angiotensin receptor blockers, aldosterone antagonists and non-steroideal anti-inflammatory medications);
- •10. Elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation of treatment that meet the requirements for permanent discontinuation of tolvaptan
- •11. Patients with anuria, volume depletion and hypernatraemia
- •12. Patients who cannot perceive or respond to thirst
- •13. Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or any other contraindication to MRI evaluation;
- •14. Psychiatric disorders and any condition that could prevent full comprehension of the purposes and risks of the study;
- •15. Pregnant or lactating;
- •16. Participation in another interventional clinical trial within the 4 weeks prior to screening.
研究者
相似试验
尚未招募
3 期
A PILOT RANDOMIZED CONTROLLED TRIAL TO STUDY THE EFFECT OF ORAL BIOENHANCED CURCUMIN IN DRY EYE DISEASECTRI/2022/01/039537rp centre of ophthalmic sciences
尚未招募
Unknown
To Investigate the change in oral bioavailability of Nicotinamide Mononucleotide (NMN, 500mg) when 5mg Bioperine is added to NMN 500mg in normal healthy volunteers.CTRI/2023/11/059982Sami-Sabinsa Group Limited
进行中（未招募）
不适用
A PILOT STUDY TESTING THE FEASIBILITY OF TWO DIFFERENTS REGIMENS INCORPORATING DOSE-DENSE DOCETAXEL AND CAPECITABINE-ORAL VINORELBINE IN THE ADJUVANT TREATMENT OF EARLY BREAST CANCER PATIENTS - DOSE DENSE DOCETAXEBREAST CANCERMedDRA version: 9.1Level: SOCClassification code 10038604EUCTR2009-015658-39-ITAZIENDA USL 4 PRATO
进行中（未招募）
不适用
A PILOT STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF A DAILY DOSE OF 500MG. LU901 (4PHENYL-BUTYRATE, CONTROLLED RELEASE TABLETS) IN ADDITION TO STANDARD HORMONAL TREATMENT IN PATIENTS WITH METASTASIZED PROSTATE CARCINOMA AND A LIFE EXPECTANCY OF AT LEAST 6 MONTHS.Patients suffering from prostate carcinoma with progression underfirst line hormonal treatment. Patients entering the study shouldhave a life expectancy prognosis of at least 6 months.MedDRA version: 12.1Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticEUCTR2010-020681-16-DEunamed Operations AG
进行中（未招募）
不适用
OPEN PILOT STUDY, TWO ARMS, WITH HISTORIC CONTROL, MULTICENTRIC TO EVALUATE SAFETY AND EFFICACY OF ASSOCIATION WITH EVEROLIMUS AND LOW DOSES OF CYCLOSPORIN AND STEROIDS AFTER INDUCTION WITH MONOCLONAL ANTIBODY ANTI CD25 IN PEDIATRIC PATIENTS AFTER KIDNEY TRANSPLANTS - NDpediatric patient after kidney transplantMedDRA version: 9.1Level: LLTClassification code 10023439Term: Kidney transplant rejectionEUCTR2008-006729-15-ITISTITUTO GIANNINA GASLINI