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Type 2 Diabetes MellitusPhase 2NCT01667614

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

A Phase 2 study testing spironolacone 25 mg tablets added to losartan in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Tehran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
spironolacone 25 mg tablets added to losartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteIran
Study dates
May 2010to Jul 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

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

    Tehran, Tehran Province, 13145-784

Other trials in Iran

About this study

Official title: Comparison of Efficacy of Losartan/Spironolactone and Losartan/Enalapril on Urinary Albumin Excretion, Estimated Glomerular Filtration Rate, and Blood Pressure in Patients With Type 2 Diabetes Nephropathy

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.

Being tested
spironolacone 25 mg tablets added to losartan
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spironolacone 25 mg tablets added to losartanDrug

    spironolactone 25 mg once daily added to losartan

Study groups in NCT01667614
Study groupRoleWhat they receive
ACE/ARBNo interventionIn 62 patients previously treated with enalapril (10-30 mg daily) + losartan (50-100 mg daily), this regimen was continued.
Spironolactone/ARBActive comparatorspironolacone 25 mg tablets added to losartan
Receives: Drug: spironolacone 25 mg tablets added to losartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary albumin excretion

    Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.

    Measured: 18 months

Secondary outcomes (4)

  1. estimated glomerular filtration rate

    estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.

    Measured: 18 months

  2. Blood pressure

    Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.

    Measured: 18 months

  3. serum creatinine concentrations

    serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.

    Measured: 18 months

  4. Serum potassium concentrations

    Serum potassium concentrations measured at baseline, 1st month, 3rd month, 6th month, 9th month, 12th month, 15th month, and 18th month.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2012 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2012
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01667614
Sponsor's protocol ID
90-2-27-16-10
Status last verified
Aug 2012
First submitted
15 Aug 2012
Last updated
28 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33107592

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing spironolacone 25 mg tablets added to losartan in people with Type 2 Diabetes Mellitus and Diabetic Nephropathy, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary albumin excretion (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667614, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.

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