ClinicalTrials.gov
ClinicalTrials.gov Menu

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01129557
Recruitment Status : Terminated
First Posted : May 24, 2010
Results First Posted : May 15, 2014
Last Update Posted : May 15, 2014
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Pietro Canetta, MD, Columbia University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Proteinuric Kidney Disease
Diabetic Nephropathy
Hypertensive Nephrosclerosis
IgA Nephropathy
Focal Segmental Glomerulosclerosis
Glomerulopathy (Obesity-associated)
Glomerulonephritis, Membranous
Interventions: Drug: Aliskiren
Drug: Valsartan

  Participant Flow

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
Diovan Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
Tekturna Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
Tekturna + Diovan Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months

Participant Flow:   Overall Study
    Diovan   Tekturna   Tekturna + Diovan
STARTED   15   17   14 
COMPLETED   11   12   10 
NOT COMPLETED   4   5   4 
Adverse Event                1                2                2 
Novartis terminated study early                3                3                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Diovan Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
Tekturna Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
Tekturna+Diovan Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
Total Total of all reporting groups

Baseline Measures
   Diovan   Tekturna   Tekturna+Diovan   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   17   14   46 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   15   17   12   44 
>=65 years   0   0   2   2 
Gender 
[Units: Participants]
       
Female   4   6   4   14 
Male   11   11   10   32 
Race/Ethnicity, Customized 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   2   3   1   6 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   1   1   1   3 
White   8   8   9   25 
More than one race   4   4   2   10 
Unknown or Not Reported   0   1   1   2 


  Outcome Measures

1.  Primary:   Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.   [ Time Frame: 9 months ]

2.  Secondary:   Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline, 3-, 6-, and 9-months ]

3.  Secondary:   Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline, 3-, 6-, and 9-months ]

4.  Secondary:   Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline, 3-, 6-, and 9-months ]

5.  Secondary:   Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline, 3-, 6-, and 9-months ]

6.  Secondary:   Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

7.  Secondary:   Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

8.  Secondary:   Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

9.  Secondary:   Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

10.  Secondary:   Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

11.  Secondary:   Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]

12.  Secondary:   Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.   [ Time Frame: Baseline and Final (9 month) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Andrew Bomback, MD
Organization: Columbia University Medical Center, Division of Nephrology
phone: 212-305-5020
e-mail: asb68@columbia.edu


Publications of Results:

Responsible Party: Pietro Canetta, MD, Columbia University
ClinicalTrials.gov Identifier: NCT01129557     History of Changes
Other Study ID Numbers: AAAE0863
#IIRP-906 ( Other Identifier: Novartis )
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: February 10, 2014
Results First Posted: May 15, 2014
Last Update Posted: May 15, 2014