Optimalization of Nephroprotection Using Agents Inhibiting Renin-Angiotensin-Aldosterone System

NCT00528385 | Completed

• 1 other identifier: ST-4/RAAS/02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study is find whether the addition of aldosterone antagonist, spironolactone to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

Conditions

Chronic Kidney Disease; Proteinuria

Keywords

Proteinuria; Renin-Angiotensin-Aldosterone System; Aldosterone Antagonists

Outcome Measures

Primary Outcomes (1)

• Investigate the antiproteinuric effect of adding aldosterone antagonist, spironolactone to the combination therapy with angiotensin converting enzyme inhibitor and AT-1 receptor blocker in maximal recommended doses.

Secondary Outcomes (1)

• Investigate the effect of the study intervention on urine excretion of N-acetyl-β-D-glucosaminidase, alfa1-microglobulin and amino-terminal propeptide of type III procollagen.

Interventions

Spironolactone (Spironol) 25 mg DRUG

In the 8-weeks run-in period ACEI, cilazapril (5 mg), telmisartan (80 mg) and hydrochlorotiazyd (12.5 mg) were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 25 mg of spironolactone in two active treatment periods lasting 8 weeks each.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• chronic kidney disease
• stable proteinuria above 300 mg/24 hours (no variations above 25% in the last 6 months)
• normal or slightly impaired stable renal function defined as serum creatinine level below 1.7 mg/dl (eGFR \> 45 ml/min)

You may not qualify if:

• nephrotic syndrome
• steroids or other immunosuppressive treatment minimum during six months before the study
• diabetes mellitus
• potassium serum level \> 5.1 mEq/L
• albumin serum level \< 2.0mg/dL
• creatinine serum level \>2 mg/dl
• current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
• clinically significant valvular heart disease or second or third degree heart block without a pacemaker
• history of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack
• history of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention
• history of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
• pregnant or nursing women
• any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
• history of alcohol abuse
• NSAID abuse (more than 2 doses per week)

Sponsors & Collaborators

• Medical University of Gdansk: lead

Related Publications (2)

• Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.

  PMID: 37466151 DERIVED

• 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: 33107592 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Spironolactone; Canrenoic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienes

Study Officials

• Boleslaw Rutkowski, MD, PhD

  Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: March 1, 2005
• Last Updated: September 12, 2007

Record last verified: 2007-09