STUDY TO ASSESS THE SHORT-TERM EFFECT OF THE ADMINISTRATION OF TOLVAPTAN AND OCTREOTIDE LAR COMPARED TO THE COMBINATION OF TOLVAPTAN AND PLACEBO IN PATIENTS AFFECTED BY ADPKD WITH NORMAL KIDNEY FUNCTION OR HYPERFILTRATIO
- Conditions
- Autosomal Dominant Policiytic Kidney DiseaseMedDRA version: 20.0 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2017-004701-40-IT
- Lead Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method