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RAS Quantification in Patients With Aliskiren or Candesartan

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Chronic Kidney Disease; Proteinuria

Intervention: RAS blockade discontinuation (Other); Aliskiren (Drug); Candesartan (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Marcus D Saemann, MD, Principal Investigator, Affiliation: Medical University of Vienna

Overall contact:
Marlies Antlanger, MD, Phone: +4369917114489, Email: marlies.antlanger@meduniwien.ac.at

Summary

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.

Clinical Details

Official title: Renin-Angiotensin-System Quantification in Patients Treated With Aliskiren or Candesartan (RASQAL)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Primary outcome: Mass spectrometry RAS peptide quantification

Secondary outcome:

Blood pressure

Proteinuria

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Marlies Antlanger, MD, Phone: +4369917114489, Email: marlies.antlanger@meduniwien.ac.at

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis, Vienna 1090, Austria; Recruiting
Marlies Antlanger, MD, Phone: +4369917114489, Email: marlies.antlanger@meduniwien.ac.at
Marcus D Saemann, MD, Principal Investigator
Marlies Antlanger, MD, Sub-Investigator
Johannes J Kovarik, MD, PhD, Sub-Investigator
Additional Information

Starting date: December 2012
Last updated: April 8, 2013

Page last updated: August 23, 2015

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