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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2006-003427-37-IT |
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Date of registration:
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27/12/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND
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Scientific title:
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Sirolimus treatment in patients with autosomal dominant polycystic kidney disease renal efficacy and safety - ND |
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Date of first enrolment:
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05/02/2007 |
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Target sample size:
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16 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003427-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: terapia convenzionale
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Italy
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Age 18 years - Clinical and ultrasound diagnosis of ADPKD - GFR 40 ml/min/1.73 m2 estimated by the 4 variable MDRD equation - Written 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Diabetes - Overt proteinuria urinary protein excretion rate 1g/24 hours or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease - Urinary tract lithiasis, infection or obstruction - Cancer - Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study - Pregnancy, lactation or child bearing potential and ineffective contraception estrogen therapy in post menopausal women should not be stopped
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Autosomal-Dominant Polycystic Kidney Disease ADPKD
MedDRA version: 9.1
Level: LLT
Classification code 10010428
Term: Congenital cystic kidney disease
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Intervention(s)
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Trade Name: RAPAMUNE*30CPR RIV 1MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Trade Name: RAPAMUNE*30CPR RIV 2MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
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Primary Outcome(s)
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Main Objective: The general aim of this randomized, open, cross-over study is to assess the efficacy and safety of 6 month treatment with sirolimus on the top of the best available therapy as compared to conventional therapy in adult patients with ADPKD and normal renal function or mild to moderate renal insufficiency. Specifically, the following aims will be pursued Main objective To compare the change over baseline of the total kidney volume estimated by computed tomography, CT in sirolimus and conventional treatment ADPKD groups during 6 month follow-up.
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Primary end point(s): To compare the change over baseline of the total kidney volume estimated by computed tomography, CT in sirolimus and conventional treatment ADPKD groups during 6 month follow-up.
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Secondary Objective: As secondary efficacy endpoints, the following parameters will be compared in the two ADPKD groups at baseline and at 6 months follow-up - Total kidney volume - Renal cyst volume - Renal parenchymal volume - Renal intermediate volume
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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