NCT00315016

Brief Summary

The purpose of this study is to determine whether eplerenone is more effective than doubling the dose of ACE inhibitor in reducing urinary protein (albumin) loss in diabetes mellitus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

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

April 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

4.5 years

First QC Date

April 14, 2006

Last Update Submit

May 25, 2012

Conditions

Diabetic Nephropathy

Keywords

albuminuriaeplerenoneACE inhibitionrenal functionendothelial function

Outcome Measures

Primary Outcomes (2)

  • proteinuria

    0, 4, 12, 24 and 30 weeks

  • blood pressure by home measurements

    0, 4, 12, 24 and 30 weeks

Secondary Outcomes (7)

  • serum potassium

    0, 3, days, 2, 4, 12, 24 and 30 weeks

  • haemoglobin

    0, 4, 12, 24 and 30 weeks

  • urinary excretion of CTGF, TGF-b, collagen IV

    0, 4, 12, 24 and 30 weeks

  • inulin and PAH clearance

    0, 24 and 30 weeks

  • Quality of Life

    0, 4, 12, 24 and 30 weeks

  • +2 more secondary outcomes

Study Arms (3)

1

PLACEBO COMPARATOR

placebo (double dummy)

Drug: placebo

2

ACTIVE COMPARATOR

eplerenone

Drug: eplerenone

3

ACTIVE COMPARATOR

doubling of fosinopril dose

Drug: fosinopril

Interventions

eplerenoneDRUG

active comparator

Also known as: Eplerenone or INSPRA
2
fosinoprilDRUG

doubling of fosinopril dose

Also known as: fosinopril or Newace
3
placeboDRUG

placebo (double dummy)

Also known as: no other name
1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • documented diabetic renal disease with albuminuria \>0.020 g/L, stable renal function (i.e. increase of serum creatinine \<25% / 6 months), creatinine clearance \> 40 ml/min/1.73 m2 , in spite of maximal ACE-inhibition (40 mg fosinopril/day)
  • blood pressure \< 140/90 mm Hg ( at baseline)
  • serum potassium \< 5.0 mmol/l (at baseline).

You may not qualify if:

  • use of NSAID's or immunosuppressive drugs
  • use of ARBs, intolerance for ACE inhibition.
  • use of diuretics that increase potassium such as triamterene, spironolactone or eplerenone
  • pregnancy
  • rash or cough on one on the drugs
  • severe heart disease or instable angina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, Netherlands

Location

University Medical Center Nijmegen St Radboud

Nijmegen, 6525 GA, Netherlands

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Diabetic NephropathiesAlbuminuria

Interventions

EplerenoneFosinopril

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPhosphinic AcidsOrganophosphorus CompoundsProlineImino AcidsAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jacob Deinum, MD

    University Medical Center Nijmegen St Radboud, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 17, 2006

Study Start

January 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations

NL(2)