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Effects of Spironolactone Combination Therapy on Proteinuria, Kidney Function, and Blood Pressure

NCT ID: NCT01667614

Last Updated: 2012-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-07-31

Brief Summary

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The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both. Recent evidence has provided robust evidence that aldostrone escape plays an important role in this regard. It is believed that aldostrone escape occurs quite commonly with reports indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial of patients with diabetes and hypertension it was shown that treatment of aldostrone escape with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number of other trials have similarly observed that addition of spironolactone to an ACE inhibitor based regimen provides additional benefits on proteinuria reduction, blood pressure control, and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in this regard are of short duration (e.g. three months), and have added spironolactone to an ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to determine the effects of addition of spironolactone 25 mg daily to losartan over a period of 18 months.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetic Nephropathy Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACE/ARB

In 62 patients previously treated with enalapril (10-30 mg daily) + losartan (50-100 mg daily), this regimen was continued.

Group Type NO_INTERVENTION

No interventions assigned to this group

Spironolactone/ARB

spironolacone 25 mg tablets added to losartan

Group Type ACTIVE_COMPARATOR

spironolacone 25 mg tablets added to losartan

Intervention Type DRUG

spironolactone 25 mg once daily added to losartan

Interventions

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spironolacone 25 mg tablets added to losartan

spironolactone 25 mg once daily added to losartan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* type 2 diabetes patients with diabetic nephropathy in the range of micro- or macroalbuminuria
* treatment with combination of enalapril and losartan for more than one year

Exclusion Criteria

* history of non-adherence to prescribed medication assessed by the prescribing physician
* baseline potassium \> 5.5 meq/L
* chronic kidney disease stages 4 or 5
* history or evidence of non-diabetic kidney disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Esteghamati

Professor Alireza Esteghamati

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alireza Esteghamati, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences, Vali-asr hospital, Endocrinology and Metabolism Research Center

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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)

Other Identifiers

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90-2-27-16-10

Identifier Type: -

Identifier Source: org_study_id