Inhibition of Aldosterone in Patients With Chronic Renal Disease

NCT ID: NCT00430924

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-08-31

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.

Detailed Description

Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.

For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Eplerenone

Group Type: ACTIVE_COMPARATOR

Eplerenone

Intervention Type: DRUG

Once daily administration for 8 weeks and 8 weeks control.

2

Control

Group Type: NO_INTERVENTION

Eplerenone

Intervention Type: DRUG

Once daily administration for 8 weeks and 8 weeks control.

Interventions

Eplerenone

Once daily administration for 8 weeks and 8 weeks control.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Lene Boesby

OTHER

Sponsor Role: lead

Responsible Party

Lene Boesby

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Svend Strandgaard, DMSc

Role: STUDY_DIRECTOR

Anne-Lise Kamper, DMSc

Role: STUDY_DIRECTOR

nonaffiliated

Locations

Rigshospitalet, Blegdamsvej 9

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 33107592 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22073219 (View on PubMed)

Related Links

http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0026904

Publication

Other Identifiers

2006-004411-21

Identifier Type: -

Identifier Source: secondary_id

B109LB1

Identifier Type: -

Identifier Source: org_study_id