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Trial record 63 of 222 for:    Aldosterone

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
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diovan Tekturna Tekturna + Diovan
Hide Arm/Group Description Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months 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
Period Title: Overall Study
Started 15 17 14
Completed 11 12 10
Not Completed 4 5 4
Reason Not Completed
Adverse Event             1             2             2
Novartis terminated study early             3             3             2
Arm/Group Title Diovan Tekturna Tekturna+Diovan Total
Hide Arm/Group Description Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months 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 of all reporting groups
Overall Number of Baseline Participants 15 17 14 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 14 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
17
 100.0%
12
  85.7%
44
  95.7%
>=65 years
0
   0.0%
0
   0.0%
2
  14.3%
2
   4.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 14 participants 46 participants
Female
4
  26.7%
6
  35.3%
4
  28.6%
14
  30.4%
Male
11
  73.3%
11
  64.7%
10
  71.4%
32
  69.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 17 participants 14 participants 46 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
1.Primary Outcome
Title Cumulative Incidence of Aldosterone Breakthrough in Subjects Who Completed the 9-month Study Protocol.
Hide Description The primary outcome of this study is the 9-month cumulative incidence of aldosterone breakthrough, defined as a sustained increase in 24-hour urine aldosterone above baseline, in each treatment arm.
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diovan Tekturna Tekturna + Diovan
Hide Arm/Group Description:
valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
Overall Number of Participants Analyzed 11 12 10
Measure Type: Number
Unit of Measure: participants
3 3 3
2.Secondary Outcome
Title Serum Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Hide Description Mean serum aldosterone at baseline, 3-, 6-, and 9-months.
Time Frame Baseline, 3-, 6-, and 9-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough 3 Months: Subjects Without Aldosterone Breakthrough 6 Months: Subjects Without Aldosterone Breakthrough 9 Months: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough 3 Months: Subjects With Aldosterone Breakthrough 6 Months: Subjects With Aldosterone Breakthrough 9 Months: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 24 24 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: ng/dL
9.1  (5.2) 4.8  (3.1) 4.9  (3.6) 4.9  (3.8) 7.3  (4.5) 8.5  (4.3) 11.7  (5.6) 11.7  (7.5)
3.Secondary Outcome
Title Urine Aldosterone Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Hide Description Mean urine aldosterone at baseline, 3-, 6-, and 9-months.
Time Frame Baseline, 3-, 6-, and 9-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough 3 Months: Subjects Without Aldosterone Breakthrough 6 Months: Subjects Without Aldosterone Breakthrough 9 Months: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough 3 Months: Subjects With Aldosterone Breakthrough 6 Months: Subjects With Aldosterone Breakthrough 9 Months: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 24 24 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: ug/day
10.9  (9.4) 4.4  (3.3) 5.5  (4.3) 4.3  (2.3) 7.4  (4.5) 11.0  (6.2) 14.4  (8.2) 12.8  (5.2)
4.Secondary Outcome
Title Serum Potassium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Hide Description Mean serum potassium at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)
Time Frame Baseline, 3-, 6-, and 9-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough 3 Months: Subjects Without Aldosterone Breakthrough 6 Months: Subjects Without Aldosterone Breakthrough 9 Months: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough 3 Months: Subjects With Aldosterone Breakthrough 6 Months: Subjects With Aldosterone Breakthrough 9 Months: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 24 24 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/L
4.2  (0.5) 4.4  (0.5) 4.4  (0.4) 4.4  (0.4) 4.3  (0.2) 4.2  (0.2) 4.3  (0.2) 4.4  (0.4)
5.Secondary Outcome
Title Mean 24-hour Urine Sodium Over Time During 9-month Treatment Course in Subjects With and Without Aldosterone Breakthrough.
Hide Description Mean 24-hour urine sodium (mmol/day) at baseline, 3-, 6-, and 9-months. (given as reference to interpret contemporaneous plasma & urine aldosterone measurements.)
Time Frame Baseline, 3-, 6-, and 9-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough 3 Months: Subjects Without Aldosterone Breakthrough 6 Months: Subjects Without Aldosterone Breakthrough 9 Months: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough 3 Months: Subjects With Aldosterone Breakthrough 6 Months: Subjects With Aldosterone Breakthrough 9 Months: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 24 24 9 9 9 9
Mean (Standard Deviation)
Unit of Measure: mmol/day
158  (67) 180  (81) 188  (66) 169  (70) 258  (98) 220  (65) 250  (102) 200  (54)
6.Secondary Outcome
Title Pre- and Post-treatment Blood Pressure in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) blood pressure for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: mm Hg
Office systolic Blood Pressure 134.0  (10.9) 122.0  (12.0) 136.3  (9.8) 127.9  (10.8)
Office diastolic Blood Pressure 83.7  (8.9) 74.0  (9.3) 87.7  (6.6) 81.6  (10.2)
7.Secondary Outcome
Title Pre- and Post-treatment Serum Creatinine in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) serum creatinine for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: mg/dL
1.2  (0.3) 1.3  (0.4) 1.2  (0.5) 1.4  (1.1)
8.Secondary Outcome
Title Pre- and Post-treatment Serum Potassium in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) serum potassium for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: (mmol/L)
4.2  (0.5) 4.4  (0.4) 4.3  (0.2) 4.4  (0.4)
9.Secondary Outcome
Title Pre- and Post-treatment 24-hour Urine Protein in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) 24-hour urine protein for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: (mg/day)
2827  (2736) 1911  (2958) 3844  (3502) 2681  (2967)
10.Secondary Outcome
Title Pre- and Post-treatment 24-hour Urine Sodium in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) 24-hour urine sodium for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: (mmol/day)
158  (67) 169  (70) 258  (98) 200  (54)
11.Secondary Outcome
Title Pre- and Post-treatment 24-urine Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) 24-hour urine aldosterone for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: (ug/day)
10.9  (9.4) 4.3  (2.3) 7.4  (4.5) 12.8  (5.2)
12.Secondary Outcome
Title Pre- and Post-treatment Serum Aldosterone in Subjects With and Without Aldosterone Breakthrough.
Hide Description Compares baseline and final (9 month) serum aldosterone for subjects with and without aldosterone breakthrough
Time Frame Baseline and Final (9 month)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline: Subjects Without Aldosterone Breakthrough Final: Subjects Without Aldosterone Breakthrough Baseline: Subjects With Aldosterone Breakthrough Final: Subjects With Aldosterone Breakthrough
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 24 24 9 9
Mean (Standard Deviation)
Unit of Measure: (ng/dL)
9.1  (5.2) 4.9  (3.8) 7.3  (4.6) 11.7  (7.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tekturna Diovan Tekturna + Diovan
Hide Arm/Group Description Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months 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
All-Cause Mortality
Tekturna Diovan Tekturna + Diovan
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tekturna Diovan Tekturna + Diovan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/15 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tekturna Diovan Tekturna + Diovan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      1/15 (6.67%)      2/14 (14.29%)    
General disorders       
Hypotension   1/17 (5.88%)  1 0/15 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders       
Headache *  1/17 (5.88%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0
Renal and urinary disorders       
>25% increase in creatinine   0/17 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash *  0/17 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Andrew Bomback, MD
Organization: Columbia University Medical Center, Division of Nephrology
Phone: 212-305-5020
EMail: asb68@columbia.edu
Layout table for additonal information
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