Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function

NCT01100203 | Terminated Phase 3 DMC

• 1 other identifier: ALBLOCK-2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy. This study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.

Conditions

Chronic Kidney Disease

Keywords

aldosterone receptor inhibition; arterial stiffness; ambulatory arterial stiffness index

Outcome Measures

Primary Outcomes (3)

• Pulse wave velocity

  Pulse wave velocity measured using the SphygmoCor device.

  24 weeks

• Pulse Wave velocity

  12 weeks

• Pulse wave velocity

  baseline

Secondary Outcomes (24)

• Ambulatory arterial stiffness index

  24 weeks

• Pulse wave analysis

  24 weeks

• Albuminuria

  baseline

• Pulse wave analysis

  baseline

• Ambulatory arterial stiffness index

  baseline

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Drug: Eplerenone

Control

NO INTERVENTION

Interventions

Eplerenone DRUG

25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years age ≤ 80 years age
• voluntarily signed informed consent
• ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate \< 60 ml/min/1,73 m2
• BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment

You may not qualify if:

• p-potassium is \> 5.0 mM
• allergy to contents
• treated with spironolactone
• treated with potent inhibitors of CYP3A4 (see SPC for details)
• treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug
• inborn errors of metabolism (see SPC for details)
• pregnancy or lactation
• fertile woman, not using safe contraception devices
• dementia or other psychiatric disorder, making understanding of the study conditions impossible
• other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement
• vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries
• systolic BP \> 200 mmHg
• immeasurable pulse amplitude

Sponsors & Collaborators

• Lene Boesby: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Dept. Nephrology, Herlev Hospital

Herlev, DK-2730, Denmark

Location

Herlev Hospital

Herlev, DK-2730, Denmark

Location

Related Publications (2)

• Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

  PMID: 33107592 DERIVED

• Boesby L, Elung-Jensen T, Strandgaard S, Kamper AL. Eplerenone attenuates pulse wave reflection in chronic kidney disease stage 3-4--a randomized controlled study. PLoS One. 2013 May 21;8(5):e64549. doi: 10.1371/journal.pone.0064549. Print 2013.

  PMID: 23704994 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lene Boesby, MD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

DK (2)