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

21 dicembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

8

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Olanda
      • Groningen, Olanda
        • Novartis Investigative Site
      • Leeuwarden, Olanda
        • Novartis Investigative Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Aliskiren
Aliskiren 150 mg (Tablet)
Droga: Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Droga: Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Droga: Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Droga: Ramipril
Ramipril 10mg (Tablet)
Sperimentale: 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.
Droga: Aliskiren
Aliskiren 150 mg (Tablet)
Droga: Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Droga: Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Droga: Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Droga: Ramipril
Ramipril 10mg (Tablet)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Sitting Systolic Blood Pressure (msSBP)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 26 weeks
26 weeks
Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments
Lasso di tempo: 26 weeks
26 weeks
Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments
Lasso di tempo: 26 weeks
26 weeks
Plasma Rennin Activity (PRA)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 26 weeks
26 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2011

Completamento primario (Effettivo)

1 dicembre 2011

Completamento dello studio (Effettivo)

1 dicembre 2011

Date di iscrizione allo studio

Primo inviato

9 febbraio 2011

Primo inviato che soddisfa i criteri di controllo qualità

22 febbraio 2011

Primo Inserito (Stima)

24 febbraio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

30 gennaio 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 dicembre 2012

Ultimo verificato

1 dicembre 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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