NCT00430924

Brief Summary

The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

February 1, 2007

Last Update Submit

February 7, 2012

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, ChronicProteinuriaAldosteroneRenin-Angiotensin System

Outcome Measures

Primary Outcomes (1)

  • Proteinuria reduction

    bi-monthly

Secondary Outcomes (1)

  • Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.

    weekly

Study Arms (2)

1

ACTIVE COMPARATOR

Eplerenone

Drug: Eplerenone

2

NO INTERVENTION

Control

Drug: Eplerenone

Interventions

EplerenoneDRUG

Once daily administration for 8 weeks and 8 weeks control.

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proteinuria \> 500 mg/24 hours
  • Hypertension or anti-hypertensive treatment

You may not qualify if:

  • Diabetic nephropathy
  • GFR\< 20 ml/min
  • P-potassium between 3,5 mmol/l and 5,0 mmol/l

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet, Blegdamsvej 9

Copenhagen, DK-2100 Ø, 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: 33107592DERIVED

  • Boesby L, Elung-Jensen T, Klausen TW, Strandgaard S, Kamper AL. Moderate antiproteinuric effect of add-on aldosterone blockade with eplerenone in non-diabetic chronic kidney disease. A randomized cross-over study. PLoS One. 2011;6(11):e26904. doi: 10.1371/journal.pone.0026904. Epub 2011 Nov 4.

    PMID: 22073219DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicProteinuria

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Svend Strandgaard, DMSc

    STUDY DIRECTOR

  • Anne-Lise Kamper, DMSc

    nonaffiliated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

February 8, 2012

Record last verified: 2012-02

Locations

DK(2)