AzTrials
AzTrials

Non-diabetic NephropathyPhase 2ARIANCT01302899

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

A Phase 2 study testing Aliskiren, Hydrochlorothiazide (HCTZ) and Ramipril in people with Non-diabetic Nephropathy, run by Novartis Pharmaceuticals at 2 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-diabetic Nephropathy
What is being tested?
Aliskiren, Hydrochlorothiazide (HCTZ) and Ramipril
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
2 sitesNetherlands
Study dates
Jan 2011to Dec 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Novartis Investigative Site

    Groningen

  • Novartis Investigative Site

    Leeuwarden

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Aliskiren, Placebo to Aliskiren, Hydrochlorothiazide (HCTZ), Placebo to Hydrochlorothiazide (HCTZ), Ramipril

What participants receive

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

  • AliskirenDrug

    Aliskiren 150 mg (Tablet)

  • Placebo to AliskirenDrug

    Aliskiren 150 mg Matching Placebo (Tablet)

  • Hydrochlorothiazide (HCTZ)Drug

    HCTZ 25mg (Capsule)

  • Placebo to Hydrochlorothiazide (HCTZ)Drug

    HCTZ 25mg (Capsule) Matching Placebo

  • RamiprilDrug

    Ramipril 10mg (Tablet)

Study groups in NCT01302899
Study groupRoleWhat they receive
Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamExperimentalPeriod 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.
Receives: Drug: Aliskiren; Drug: Placebo to Aliskiren; Drug: Hydrochlorothiazide (HCTZ); Drug: Placebo to Hydrochlorothiazide (HCTZ); Drug: Ramipril
Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/RamExperimentalPeriod 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.
Receives: Drug: Aliskiren; Drug: Placebo to Aliskiren; Drug: Hydrochlorothiazide (HCTZ); Drug: Placebo to Hydrochlorothiazide (HCTZ); Drug: Ramipril

What is being measured

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

  1. Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)

    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.

    Measured: 26 weeks

  2. Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin

    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.

    Measured: 26 weeks

Secondary outcomes (9)

  1. Mean Sitting Systolic Blood Pressure (msSBP)

    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.

    Measured: 26 weeks

  2. Mean Sitting Diastolic Blood Pressure (msDBP)

    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.

    Measured: 26 weeks

  3. Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function

    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.

    Measured: 26 weeks

  4. Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments

    Measured: 26 weeks

  5. Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments

    Measured: 26 weeks

  6. Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments

    Measured: 26 weeks

  7. Plasma Rennin Activity (PRA)

    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.

    Measured: Baseline to week 26

  8. Plasma Rennin Concentration (PRC)

    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.

    Measured: Baseline to week 26

  9. Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril

    Measured: 26 weeks

Timeline

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

  1. First posted24 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Why it stopped: In consequence of termination of ALTITUDE. A number of studies were continued in consultation with the Altitude Data Monitoring Committee.

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302899
Sponsor's protocol ID
CSPP100A2260
Other IDs
2009-012196-10, 2009
Acronym
ARIA
Status last verified
Dec 2012
First submitted
9 Feb 2011
Last updated
30 Jan 2013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aliskiren, Hydrochlorothiazide (HCTZ) and Ramipril in people with Non-diabetic Nephropathy, run by Novartis Pharmaceuticals at 2 sites in Netherlands.

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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. 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?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER) (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 NCT01302899.

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 30 Jan 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in