Effects of Sirolimus on disease progression in patients with Autosomal Dominant Polycystic Kidney Disease and severe renal insufficiency - SIRENA II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005047-21-IT

Enrollment

Registered

2008-07-02

Start date

2007-12-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) MedDRA version: 9.1 Level: LLT Classification code 10010428 Term: Congenital cystic kidney disease

Interventions

Trade Name: RAPAMUNE*100CPR RIV 1MG Pharmaceutical Form: Tablet INN or Proposed INN: Sirolimus Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age > 18 years - Clinical and ultrasound diagnosis of ADPKD - GFR =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.;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);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.	—

Measure

Time frame

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.;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);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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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026