RAS Quantification in Patients With Aliskiren or Candesartan (RASQAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01827202
First received: April 4, 2013
Last updated: April 8, 2013
Last verified: April 2013

April 4, 2013
April 8, 2013
December 2012
September 2013   (final data collection date for primary outcome measure)
Mass spectrometry RAS peptide quantification [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Quantitative RAS peptide changes determined by mass spectrometry after a 2-month treatment with aliskiren or candesartan
Same as current
Complete list of historical versions of study NCT01827202 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Blood pressure reduction, determined by ambulatory blood pressure measurements at study start and end
  • Proteinuria [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Proteinuria reduction, measured by urinary albumin/creatinine ratio at study start and end
Same as current
Not Provided
Not Provided
 
RAS Quantification in Patients With Aliskiren or Candesartan
Renin-Angiotensin-System Quantification in Patients Treated With Aliskiren or Candesartan (RASQAL)

Forced blockade of the renin-angiotensin-system (RAS) by using direct renin inhibition (DRI) has long been propagated to effectuate beneficial outcomes. However, recent large clinical trials have outlined harmful effects for DRI in combination with other forms of RAS blockade. To date, information regarding DRI as RAS-blocking monotherapy is very limited. Furthermore, it remains to be elucidated how DRI and angiotensin receptor blockers affect the so-called 'classical' and 'alternative' RAS molecularly. As components of the 'alternative' RAS (e.g. Ang 1-7) have moved into research focus, it would be of importance to determine angiotensin regulation with medical RAS blockade.

In this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic kidney disease (CKD) stage III-IV (eGFR 15-59 ml/min) will be randomized to take either aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in phase where all RAS-blockers are eliminated. The investigators will then employ a novel mass spectrometry-based quantification method (after run-in and 10 weeks) to capture the concentrations of ten different angiotensin peptides (including angiotensin I and II, angiotensin 1-7 and angiotensin 1-5).

The investigators hypothesize that significant differences exist between angiotensin levels in CKD patients with DRI compared to angiotensin receptor blockers. Specifically, the investigators expect to determine the regulation of the alternative RAS represented by angiotensin 1-7 with proximal versus distal blockade of the system.

Our data might contribute to a more profound understanding of results from registries and clinical trials beyond the clinical effects of RAS blockade. Further, the study's results might help to individualize and optimize RAS-blocking therapy strategies in CKD patients.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Hypertension
  • Chronic Kidney Disease
  • Proteinuria
  • Other: RAS blockade discontinuation
    In the initial two weeks of the study, all RAS blockade will be eliminated from the subjects' antihypertensive regimen
  • Drug: Aliskiren
    Other Name: Rasilez
  • Drug: Candesartan
    Other Name: Atacand
  • Active Comparator: Aliskiren
    After a two-week phase where all RAS blockade is eliminated, patients in this arm will commence taking aliskiren 150 mg once daily for 4 weeks. Thereafter, the dose will be increased to 300 mg once daily for another 4 weeks.
    Interventions:
    • Other: RAS blockade discontinuation
    • Drug: Aliskiren
  • Active Comparator: Candesartan
    After a two-week phase where all RAS blockade is eliminated, patients in this arm will commence taking candesartan 8 mg once daily for 4 weeks. Thereafter, the dose will be increased to 16 mg once daily for another 4 weeks.
    Interventions:
    • Other: RAS blockade discontinuation
    • Drug: Candesartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
Not Provided
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chronic kidney disease stages III-IV (defined by modification of diet in renal disease (MDRD) formula)
  • Urinary albumin to creatinine ratio (UACR) >300mg/g, UACR >200mg/g if already receiving RAS blockade
  • Arterial hypertension

Exclusion Criteria:

  • Age <18 years
  • Diabetes mellitus type 2 (defined by WHO criteria)
  • Chronic kidney disease stage V (end-stage renal disease)
  • UACR >3500mg/g
  • Severe hypertension (systolic blood pressure >180mmHg)
  • Pregnancy
Both
18 Years and older
No
Contact: Marlies Antlanger, MD +4369917114489 marlies.antlanger@meduniwien.ac.at
Austria
 
NCT01827202
EK-Nr. 011/2012
Yes
Marcus Saemann, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Marcus D Saemann, MD Medical University of Vienna
Medical University of Vienna
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP