Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney - Full Text View

Purpose

The purpose of this study is to determine which combination of the tablets ramipril, irbesartan or spironolactone is best to lower protein leakage from the kidney.

Condition	Intervention	Phase
Kidney Disease Diabetic Nephropathy Glomerulonephritis Proteinuria	Drug: Spironolactone Drug: Irbesartan	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	A Double-Blind, Placebo-Controlled Study on the Effect of Spironolactone, in Patients With Persistent Proteinuria on Long-Term Angiotensin Converting Enzyme Inhibitor Therapy, With or With Out an Angiotensin II Receptor Blocker

Resource links provided by NLM:

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Spironolactone Irbesartan

Genetic and Rare Diseases Information Center resources: Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

percent reduction in 24 hour urine protein excretion


Estimated Enrollment:	60
Study Start Date:	January 2002
Estimated Study Completion Date:	September 2004

Detailed Description:

Protein leak from the kidney into the urine is an indicator of kidney damage. The higher the leak, the worse the damage and the more likely the patient will lose their kidney function long term. Interventions that lower protein leak make the kidneys last longer.

There are 2 groups of medications, both blood pressure tablets, the ACEI (angiotensin converting enzyme inhibitors) and ATRB (angiotensin receptor blockers) which have shown to reduce the amount of protein leaking from the kidney and as a result lengthen the life of the kidney. There has also been evidence that using these 2 tablets in combination is better than using either one alone. In spite of these tablets, there still remain some patients that continue to leak protein in the urine.

Recently there has been evidence that the tablet spironolactone, which is a fluid tablet, also reduces protein leakage from the kidney. In this study we look at various combinations of these tablets to see which works best to lower protein leakage from the kidney.

Patients are divided into 4 groups. Each group will receive the tablet ramipril (an ACEI). In group 1, patients will be on ramipril and 2 blank tablets, group 2 will be on ramipril, irbesartan (an ATRB) and a blank tablet, group 3 will be on ramipril, spironolactone and a blank tablet and group 4 will be on ramipril, irbesartan and spironolactone. Protein leakage is measured at the beginning and after 3 months of treatment.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Proteinuria more than 1.5 g/day
On ACEI for more than 6 months
Serum creatinine less than 200 micromol/L with less than 20% variability in the preceeding 3 months
Creatinine clearance more than 30 ml/min, with less than 20% variability in the preceeding 3 months

Exclusion Criteria:

Serum potassium level more than 5 mmol/L
Treatment with corticosteroids, NSAID or immunosuppressant medication
Acute myocardial infarction or cerebrovascular accident in the previous 6 months
Severe uncontrolled hypertension (diastolic > 115 mmHg or systolic BP [blood pressure] > 220 mmHg)
Evidence or suspicion of renovascular disease, obstructive uropathy, collagen disease, cancer, drug or alcohol abuse, pregnancy, or breast feeding and ineffective contraception

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106561

Locations


Australia, Victoria
Department of Nephrology, The Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050

Sponsors and Collaborators

Melbourne Health

Investigators


Study Director:	Gavin G Becker, MBBS MD	Director Department of Nephrology, The Royal Melbourne Hospital

More Information

Publications:

Chrysostomou A, Becker G. Spironolactone in addition to ACE inhibition to reduce proteinuria in patients with chronic renal disease. N Engl J Med. 2001 Sep 20;345(12):925-6.


ClinicalTrials.gov Identifier:	NCT00106561 History of Changes
Other Study ID Numbers:	RMH2001-142
Study First Received:	March 25, 2005
Last Updated:	June 23, 2005
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Melbourne Health:


spironolactone proteinuria angiotensin converting enzyme inhibitor	angiotensin receptor blocker renin angiotensin aldosterone system aldosterone

Additional relevant MeSH terms:


Diabetic Nephropathies Glomerulonephritis Kidney Diseases Proteinuria Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nephritis Signs and Symptoms Urination Disorders Urologic Diseases Urological Manifestations Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors	Spironolactone Cardiovascular Agents Diuretics Diuretics, Potassium Sparing Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mineralocorticoid Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015