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

This study has been terminated.
(In consequence of termination of ALTITUDE. A number of studies were continued in consultation with the Altitude Data Monitoring Committee.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01302899
First received: February 9, 2011
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
Results First Received: December 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Non-diabetic Nephropathy
Interventions: Drug: Aliskiren
Drug: Placebo to Aliskiren
Drug: Hydrochlorothiazide (HCTZ)
Drug: Placebo to Hydrochlorothiazide (HCTZ)
Drug: Ramipril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow for 4 periods

 Period 1:   Period 1 (Day 1 to End of Week 6)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram     Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram  
STARTED     4     4  
COMPLETED     4     4  
NOT COMPLETED     0     0  

Period 2:   Period 2 (Weeks 7 to 12)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram     Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram  
STARTED     4     4  
COMPLETED     3     3  
NOT COMPLETED     1     1  
Protocol Deviation                 1                 0  
Abnormal laboratory value(s)                 0                 1  

Period 3:   Period 3 (Weeks 13 to 18)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram     Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  

Period 4:   Period 4 (Weeks 19 to 26)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram     Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram     Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram     Total  
Number of Participants  
[units: participants]
 		  4     4     8  
Age  
[units: years]
Mean ± Standard Deviation 		  50.5  ± 6.76     58.5  ± 8.70     54.5  ± 8.38  
Gender  
[units: participants]
 		     
Female     2     1     3  
Male     2     3     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)   [ Time Frame: 26 weeks ]
  Show Outcome Measure 1

2.  Primary:   Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin   [ Time Frame: 26 weeks ]
  Show Outcome Measure 2

3.  Secondary:   Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: 26 weeks ]
  Show Outcome Measure 3

4.  Secondary:   Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: 26 weeks ]
  Show Outcome Measure 4

5.  Secondary:   Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function   [ Time Frame: 26 weeks ]
  Show Outcome Measure 5

6.  Secondary:   Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]
  Show Outcome Measure 7

8.  Secondary:   Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Plasma Rennin Activity (PRA)   [ Time Frame: Baseline to week 26 ]
  Show Outcome Measure 9

10.  Secondary:   Plasma Rennin Concentration (PRC)   [ Time Frame: Baseline to week 26 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril   [ Time Frame: 26 weeks ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01302899     History of Changes
Other Study ID Numbers: CSPP100A2260, 2009-012196-10
Study First Received: February 9, 2011
Results First Received: December 21, 2012
Last Updated: December 21, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)