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Dose Finding Study to Treat High Phosphate Levels in the Blood.

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ClinicalTrials.gov Identifier: NCT02081534
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ardelyx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hyperphosphatemia
Interventions Drug: AZD1722
Drug: Placebo
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Hide Arm/Group Description

1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 od

AZD1722: tenapanor, oral tablet

30 mg AZD1722 od

AZD1722: tenapanor, oral tablet

Placebo (double dummy technique)

Placebo: Placebo bid, double dummy technique

Period Title: Overall Study
Started 23 21 23 26 22 21 26
Completed 18 13 19 13 18 12 22
Not Completed 5 8 4 13 4 9 4
Reason Not Completed
Adverse Event             5             4             3             10             2             8             2
Withdrawal by Subject             0             1             1             1             1             0             1
Protocol Violation             0             3             0             0             0             0             1
Lost to Follow-up             0             0             0             2             1             1             0
Arm/Group Title 1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo Total
Hide Arm/Group Description

1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 od

AZD1722: tenapanor, oral tablet

30 mg AZD1722 od

AZD1722: tenapanor, oral tablet

Placebo (double dummy technique)

Placebo: Placebo bid, double dummy technique

Total of all reporting groups
Overall Number of Baseline Participants 23 21 23 26 22 21 26 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 21 participants 23 participants 26 participants 22 participants 21 participants 26 participants 162 participants
57.9  (14.79) 61.5  (11.21) 62.7  (12.53) 59.7  (12.96) 57.6  (15.78) 58.2  (15.75) 56.1  (13.14) 59.1  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 26 participants 22 participants 21 participants 26 participants 162 participants
Female
16
  69.6%
15
  71.4%
15
  65.2%
17
  65.4%
12
  54.5%
13
  61.9%
16
  61.5%
104
  64.2%
Male
7
  30.4%
6
  28.6%
8
  34.8%
9
  34.6%
10
  45.5%
8
  38.1%
10
  38.5%
58
  35.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 26 participants 22 participants 21 participants 26 participants 162 participants
Hispanic or Latino
7
  30.4%
7
  33.3%
10
  43.5%
4
  15.4%
8
  36.4%
6
  28.6%
6
  23.1%
48
  29.6%
Not Hispanic or Latino
16
  69.6%
14
  66.7%
13
  56.5%
22
  84.6%
14
  63.6%
15
  71.4%
20
  76.9%
114
  70.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 26 participants 22 participants 21 participants 26 participants 162 participants
American Indian or Alaska Native
0
   0.0%
1
   4.8%
1
   4.3%
1
   3.8%
2
   9.1%
1
   4.8%
2
   7.7%
8
   4.9%
Asian
1
   4.3%
0
   0.0%
3
  13.0%
1
   3.8%
1
   4.5%
0
   0.0%
3
  11.5%
9
   5.6%
Native Hawaiian or Other Pacific Islander
1
   4.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
Black or African American
2
   8.7%
8
  38.1%
3
  13.0%
9
  34.6%
6
  27.3%
3
  14.3%
4
  15.4%
35
  21.6%
White
17
  73.9%
12
  57.1%
16
  69.6%
15
  57.7%
13
  59.1%
16
  76.2%
17
  65.4%
106
  65.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   8.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
3
   1.9%
serum phosphorus  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 23 participants 21 participants 23 participants 26 participants 22 participants 21 participants 26 participants 162 participants
7.55  (1.003) 7.92  (1.005) 7.32  (1.063) 7.76  (1.183) 7.73  (1.276) 7.61  (0.847) 7.87  (1.488) 7.68  (1.124)
1.Primary Outcome
Title Change in Serum Phosphate Levels
Hide Description Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Time Frame End of wash out (pre randomization value) to end of treatment (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
two patients in the 30 mg bid group are not included in the analysis since they had no post randomization serum phosphorus measurements
Arm/Group Title 1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Hide Arm/Group Description:

1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 od

AZD1722: tenapanor, oral tablet

30 mg AZD1722 od

AZD1722: tenapanor, oral tablet

Placebo (double dummy technique)

Placebo: Placebo bid, double dummy technique

Overall Number of Participants Analyzed 23 21 23 24 22 21 26
Least Squares Mean (Standard Deviation)
Unit of Measure: mg/dL
-.47  (1.553) -1.18  (1.391) -1.7  (2.018) -1.98  (2.007) -.56  (1.763) -1.11  (1.469) -.54  (1.802)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg Bid, 3 mg Bid, 10 mg Bid, 30 mg Bid, 3 mg od, 30 mg od, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Calcium x Phosphorus Product
Hide Description Change from baseline (end of wash out) in calcium x phosphorus product
Time Frame End of wash out (pre randomization value) to end of treatment (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
The number of patients analyzed are less than the randomized number since the data to accomplish the analysis was not available.
Arm/Group Title 1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Hide Arm/Group Description:

1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 od

AZD1722: tenapanor, oral tablet

30 mg AZD1722 od

AZD1722: tenapanor, oral tablet

Placebo (double dummy technique)

Placebo: Placebo bid, double dummy technique

Overall Number of Participants Analyzed 22 19 20 23 21 20 24
Mean (Standard Deviation)
Unit of Measure: mg/dL * mg/dL
-5.16  (9.75) -12.02  (14.02) -12.44  (15.94) -16.6  (18.01) -3.59  (18.59) -11.02  (11.57) -2.50  (13.67)
Time Frame Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Hide Arm/Group Description

1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet

3 mg AZD1722 od

AZD1722: tenapanor, oral tablet

30 mg AZD1722 od

AZD1722: tenapanor, oral tablet

Placebo (double dummy technique)

Placebo: Placebo bid, double dummy technique

All-Cause Mortality
1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/23 (4.35%)      0/21 (0.00%)      0/23 (0.00%)      0/26 (0.00%)      0/22 (0.00%)      0/21 (0.00%)      0/26 (0.00%)    
Hide Serious Adverse Events
1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/23 (8.70%)      2/21 (9.52%)      3/23 (13.04%)      2/26 (7.69%)      1/22 (4.55%)      0/21 (0.00%)      4/26 (15.38%)    
Blood and lymphatic system disorders               
Anemia * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/26 (3.85%)  1
Cardiac disorders               
Chest pain * 1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/23 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Cardiac failure * 1  1/23 (4.35%)  1 0/21 (0.00%)  0 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Acute Myocardial Infarction * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/26 (3.85%)  1
Gastrointestinal disorders               
Rectal prolapse * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
diarrhea * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations               
pneumonia * 1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 1/26 (3.85%)  1
osteomyelitis * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/23 (4.35%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Injury, poisoning and procedural complications               
Head injury * 1  0/23 (0.00%)  0 1/21 (4.76%)  1 0/23 (0.00%)  0 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Metabolism and nutrition disorders               
Fluid overload * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/23 (4.35%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Nervous system disorders               
Syncope * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 1/23 (4.35%)  1 0/26 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
Lacunar infarction * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 0/26 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0 0/26 (0.00%)  0
Vascular disorders               
Deep vein thrombosis * 1  0/23 (0.00%)  0 0/21 (0.00%)  0 0/23 (0.00%)  0 1/26 (3.85%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0 0/26 (0.00%)  0
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 mg Bid 3 mg Bid 10 mg Bid 30 mg Bid 3 mg od 30 mg od Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/23 (26.09%)      6/21 (28.57%)      11/23 (47.83%)      17/26 (65.38%)      4/22 (18.18%)      11/21 (52.38%)      3/26 (11.54%)    
Gastrointestinal disorders               
Diarrhea * 1  6/23 (26.09%)  6 6/21 (28.57%)  6 11/23 (47.83%)  11 17/26 (65.38%)  17 4/22 (18.18%)  4 11/21 (52.38%)  11 3/26 (11.54%)  3
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Development Officer
Organization: Ardelyx
Phone: 6175134929
EMail: drosenbaum@ardelyx.com
Layout table for additonal information
Responsible Party: Ardelyx
ClinicalTrials.gov Identifier: NCT02081534    
Other Study ID Numbers: D5613C00001
First Submitted: March 6, 2014
First Posted: March 7, 2014
Results First Submitted: August 6, 2020
Results First Posted: September 14, 2020
Last Update Posted: September 14, 2020