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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: |
EUCTR2007-005047-21-IT |
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Date of registration:
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02/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II
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Scientific title:
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Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II |
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Date of first enrolment:
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24/12/2007 |
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Target sample size:
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40 |
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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:2007-005047-21 |
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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: yes
Cross over: no
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) - Urinary protein excretion rate < 0.5 g/ 24 hrs - 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 - Urinary protein excretion rate >0.5 g/ 24 hrs 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*100CPR 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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Secondary Objective: 1. Slope of GFR by measuring plasma iohexol clearance at baseline and every 6 months thereafter 2. Renal plasma flow (RPF) by measuring plasma PAH clearance at baseline and every 6 months thereafter 3. Profile of serum creatinine concentration (every 3 months) 4. Systolic and diastolic blood pressure (every 3 months) 5. 24 hours urinary protein excretion (baseline and every 6 months) 6. Urinary sodium, urea, glucose, phosphorus concentrations (24hr samples) at baseline and every 6 months 7. Urinary osmolality (baseline, every 6 months)
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Primary end point(s): To compare the change over baseline of renal function (estimated by Delta GFR, measured by plasma iohexol clearance) in SRL and conventional treatment ADPKD patients with severe renal insufficiency (<40ml/min/1.73m2) after one year follow-up.
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Main Objective: To compare the change over baseline of renal function (estimated by Delta GFR, measured by plasma iohexol clearance) in SRL and conventional treatment ADPKD patients with severe renal insufficiency (<40ml/min/1.73m2) after one year follow-up.
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Secondary ID(s)
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SIRENA II
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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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