Renin-Angiotensin System Quantification in patients treated with specific medication against hypertension (Aliskiren or Candesartan)

Renin-Angiotensin System Quantification in patients treated with Aliskiren or Candesartan (RASQAL) - RASQAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000250-55-AT

Enrollment

Unknown

Registered

2012-06-11

Start date

2012-07-12

Completion date

Unknown

Last updated

2017-01-23

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

Conditions

None listed

Interventions

Trade Name: Rasilez Pharmaceutical Form: Film-coated tablet CAS Number: 173334-57-1 Other descriptive name: ALISKIREN HEMIFUMARATE Concentration unit: mg milligram(s) Concentration type: up to Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Chronic kidney disease stages III-IV (defined by MDRD formula) - Urinary albumin to creatinine ratio (UACR) >300mg/g, UACR >200mg/g if already receiving RAS blockade - Hypertension 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 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24

Exclusion criteria

Exclusion criteria: Age 3500mg/g, severe hypertension, pregnancy

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To determine if patients who receive single RAS blockade exhibit rebound upregulation of potentially beneficial components of the RAS system. To demonstrate if patients receiving aliskiren exhibit complete suppression of the RAS system components. To demonstrate potential additional blood pressure lowering effects in patients receiving direct renin inhibition or angiotensin receptor blockade. To demonstrate potential additional antiproteinuric effects in patients receiving direct renin inhibition or angiotensin receptor blockade. ;Main Objective: To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.;Primary end point(s): Efficacy: Quantitative RAS peptide changes determined by mass spectrometry after a 2 month treatment with aliskiren or ARB Safety: Number of hypotensive episodes experienced by patients receiving study drugs Number of hospitalizations during study phases ;Timepoint(s) of evaluation of this end point: after a 2 month treatment	—

Measure

Time frame

Secondary Objective: To determine if patients who receive single RAS blockade exhibit rebound upregulation of potentially beneficial components of the RAS system. To demonstrate if patients receiving aliskiren exhibit complete suppression of the RAS system components. To demonstrate potential additional blood pressure lowering effects in patients receiving direct renin inhibition or angiotensin receptor blockade. To demonstrate potential additional antiproteinuric effects in patients receiving direct renin inhibition or angiotensin receptor blockade. ;Main Objective: To demonstrate the quantity of differences in the renin-angiotensin peptide profiles in patients receiving direct renin inhibition or angiotensin receptor blockade.;Primary end point(s): Efficacy: Quantitative RAS peptide changes determined by mass spectrometry after a 2 month treatment with aliskiren or ARB Safety: Number of hypotensive episodes experienced by patients receiving study drugs Number of hospitalizations during study phases ;Timepoint(s) of evaluation of this end point: after a 2 month treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy: Extent of RAS suppression with aliskiren, determined by mass spectrometry measurements after aliskiren study phase Blood pressure reduction, determined by ambulatory blood pressure measurements Proteinuria reduction, measured by UACR after each study phase ;Timepoint(s) of evaluation of this end point: after study phase of 2 months	—

Countries

Austria

Outcome results