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To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy (ARIA)

21 december 2012 bijgewerkt door: Novartis Pharmaceuticals

A Single-blind, Double Dummy, Randomized, Multi-dose, Two Sequence, Crossover, Study to Investigate the Effects of Renin Inhibitor (Aliskiren 300 mg) on Albuminuria in Non-diabetic Nephropathy Patients Treated With Ramipril 10 mg and Volume Intervention (ARIA)

The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

8

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Nederland
      • Groningen, Nederland
        • Novartis Investigative Site
      • Leeuwarden, Nederland
        • Novartis Investigative Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Male and female subjects, age 18 years and above
  • Patients with chronic kidney disease of non-diabetic origin
  • Glomerular filtration rate >30 ml/min/1.73m2
  • Patients with a history of hypertension and msSBP (mean systolic blood pressure) of <160 mm Hg and msDBP (mean diastolic blood pressure) <105 mm Hg at screening and baseline.
  • Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2

Exclusion Criteria:

  • Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
  • Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
  • Pregnant or nursing (lactating) women,
  • A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
  • Diabetes mellitus, Heart failure
  • High rate of renal function loss
  • History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
  • History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Other protocol-defined inclusion/exclusion criteria applied

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Geneesmiddel: Aliskiren
Aliskiren 150 mg (Tablet)
Geneesmiddel: Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Geneesmiddel: Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Geneesmiddel: Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Geneesmiddel: Ramipril
Ramipril 10mg (Tablet)
Experimenteel: Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Geneesmiddel: Aliskiren
Aliskiren 150 mg (Tablet)
Geneesmiddel: Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Geneesmiddel: Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Geneesmiddel: Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Geneesmiddel: Ramipril
Ramipril 10mg (Tablet)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
Tijdsspanne: 26 weeks
Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
26 weeks
Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin
Tijdsspanne: 26 weeks
Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.
26 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean Sitting Systolic Blood Pressure (msSBP)
Tijdsspanne: 26 weeks
At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Systolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msSBP was calculated. All BP measurements were to be performed on the same arm.
26 weeks
Mean Sitting Diastolic Blood Pressure (msDBP)
Tijdsspanne: 26 weeks
At study entry, blood pressure (BP) was measured in both arms. If there was a clinically relevant difference in readings between arms (≥ 10 mmHg in systolic BP and/or ≥ 5 mmHg in diastolic BP), the arm with higher BP reading was used. If there was no clinically significant difference between arms, the non-dominant arm was used through out study. Diastolic blood pressure were assessed after the patient rested quietly in the sitting position for at least 3 minutes. For each sitting assessment, blood pressure was assessed at least 3 times. From these assessments, msDBP was calculated. All BP measurements were to be performed on the same arm.
26 weeks
Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function
Tijdsspanne: 26 weeks
All patients had to visit the main center for renal function measurements. The measurements were performed using the constant infusion method with I-iothalamate (IOT) and I-hippuran. GFR was calculated as the urinary clearance of IOT.
26 weeks
Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments
Tijdsspanne: 26 weeks
26 weeks
Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
Tijdsspanne: 26 weeks
26 weeks
Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
Tijdsspanne: 26 weeks
26 weeks
Plasma Rennin Activity (PRA)
Tijdsspanne: Baseline to week 26
Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. Plasma PRA is a direct measure of the formation of Ang I in the plasma.
Baseline to week 26
Plasma Rennin Concentration (PRC)
Tijdsspanne: Baseline to week 26
Blood biomarkers were obtained from blood samples in all patients at the time points such as baseline, week 6, week 12, week 18 and week 26. PRC measures the concentration of immunoactive renin in the plasma.
Baseline to week 26
Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril
Tijdsspanne: 26 weeks
26 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2011

Primaire voltooiing (Werkelijk)

1 december 2011

Studie voltooiing (Werkelijk)

1 december 2011

Studieregistratiedata

Eerst ingediend

9 februari 2011

Eerst ingediend dat voldeed aan de QC-criteria

22 februari 2011

Eerst geplaatst (Schatting)

24 februari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

30 januari 2013

Laatste update ingediend die voldeed aan QC-criteria

21 december 2012

Laatst geverifieerd

1 december 2012

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CSPP100A2260
  • 2009-012196-10 (EudraCT-nummer)

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