Trial Outcomes & Findings for Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease (NCT NCT03071263)
NCT ID: NCT03071263
Last Updated: 2021-05-12
Results Overview
The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
At week 12
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
Group 1 - Patiromer
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
148
|
|
Overall Study
COMPLETED
|
144
|
141
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Group 1 - Patiromer
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Participant moved to another city
|
0
|
1
|
Baseline Characteristics
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
98 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 12.24 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
68.1 years
STANDARD_DEVIATION 11.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
145 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline central laboratory serum potassium
Baseline serum potassium <4.3 mEq/L
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Baseline central laboratory serum potassium
Baseline serum potassium 4.3-<4.7 mEq/L
|
55 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Baseline central laboratory serum potassium
Baseline serum potassium 4.7-5.1 mEq/L
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Baseline central laboratory serum potassium
Baseline serum potassium >5.1 mEq/L
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Baseline eGFR
|
35.37 mL/min/1.73m^2
STANDARD_DEVIATION 7.274 • n=5 Participants
|
36.08 mL/min/1.73m^2
STANDARD_DEVIATION 7.597 • n=7 Participants
|
35.73 mL/min/1.73m^2
STANDARD_DEVIATION 7.434 • n=5 Participants
|
|
Systolic blood pressure as measured using automated office blood pressure device (AOBP SBP)
|
143.3 mmHg
STANDARD_DEVIATION 6.48 • n=5 Participants
|
144.9 mmHg
STANDARD_DEVIATION 7.01 • n=7 Participants
|
144.1 mmHg
STANDARD_DEVIATION 6.79 • n=5 Participants
|
|
Antihypertensive Medications at Baseline
Perindopril
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Valsartan
|
38 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Losartan
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Indapamide
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Hydrochlorothiazide
|
52 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Furosemide
|
26 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Torasemide
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Amlodipine
|
74 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Lercanidipine
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Bisoprolol
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Nebivolol
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Antihypertensive Medications at Baseline
Other antihypertensives
|
40 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Number of Participants Remaining on Spironolactone at Week 12
|
126 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure
Outcome measures
| Measure |
Group 1 - Patiromer
n=144 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=141 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications
|
-11.3 mmHg
Standard Deviation 14.11
|
-11.0 mmHg
Standard Deviation 15.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
AOBP SBP: Automated Office Systolic Blood Pressure
Outcome measures
| Measure |
Group 1 - Patiromer
n=144 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=141 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives
|
-11.3 mmHg
Standard Deviation 14.11
|
-11.2 mmHg
Standard Deviation 15.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Table depicts those participants with values at Baseline and Week 12. Those participants with no available results at W12 were not included in the table below.
The two baseline potassium subgroups, 4.3-\<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.
Outcome measures
| Measure |
Group 1 - Patiromer
n=144 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=140 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category
Baseline Central Serum Potassium 4.3-<4.7 mEq/L
|
0.16 mEq/L
Standard Deviation 0.468
|
0.40 mEq/L
Standard Deviation 0.494
|
|
Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category
Baseline Central Serum Potassium 4.7-<5.1 mEq/L
|
-0.09 mEq/L
Standard Deviation 0.442
|
0.03 mEq/L
Standard Deviation 0.468
|
|
Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category
Overall
|
0.02 mEq/L
Standard Deviation 0.469
|
0.20 mEq/L
Standard Deviation 0.514
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Table depicts those participants with values at mentioned time frame. Those participants with no available results were not included in the table below.
Baseline Central Serum Potassium: BCSP. The symbols \> and ≤ included in the row titles are used to indicate the time interval \["\>Week1 and ≤Week2" meaning from day 8 until day 14 (included)\]. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP \<4.3 mEq/L or \>5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period.
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: ≤Week1
|
60 Participants
|
62 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week1 and ≤Week2
|
57 Participants
|
57 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week 2 and ≤Week 3
|
59 Participants
|
63 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week 3 and ≤Week 4
|
61 Participants
|
60 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week 4 and ≤Week 6
|
61 Participants
|
61 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week 6 and ≤Week 8
|
61 Participants
|
58 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: >Week 8 and ≤Week 10
|
58 Participants
|
58 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.3-<4.7mEq/L: > Week 10 and ≤ Week 12
|
61 Participants
|
61 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1 mEq/L: ≤Week 1
|
75 Participants
|
66 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 1 and ≤Week 2
|
74 Participants
|
65 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 2 and ≤Week 3
|
74 Participants
|
65 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 3 and ≤Week 4
|
74 Participants
|
61 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1 mEq/L: >Week 4 and ≤Week 6
|
79 Participants
|
64 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 6 and ≤Week 8
|
74 Participants
|
66 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 8 and ≤Week 10
|
72 Participants
|
66 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
BCSP 4.7-<5.1mEq/L: >Week 10 and ≤Week 12
|
80 Participants
|
65 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : ≤Week 1
|
135 Participants
|
128 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : > Week 1 and ≤Week 2
|
131 Participants
|
122 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 2 and ≤Week 3
|
133 Participants
|
128 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 3 and ≤Week 4
|
135 Participants
|
121 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 4 and ≤Week 6
|
140 Participants
|
125 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 6 and ≤Week 8
|
135 Participants
|
124 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 8 and ≤Week 10
|
130 Participants
|
124 Participants
|
|
Participants With Central Serum Potassium <5.5 mEq/L Over Time
Overall : >Week 10 and ≤Week 12
|
141 Participants
|
126 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 12Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Reported results only include the number of participants having spironolactone titrations over time according to the classification defined below.
The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate The symbols \> and ≤ included in the row titles are used to indicate the time interval \["\>Week1 and ≤Week2" meaning from day 8 until day 14 (included)\].
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Participants Having Spironolactone Titrations Over Time
Up : ≤Week 1
|
0 Participants
|
0 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 1 and ≤Week 2
|
0 Participants
|
0 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 2 and ≤Week 3
|
88 Participants
|
77 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 3 and ≤Week 4
|
27 Participants
|
21 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 4 and ≤Week 6
|
10 Participants
|
11 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 6 and ≤Week 8
|
6 Participants
|
6 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 8 and ≤Week 10
|
6 Participants
|
7 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Up : >Week 10 and ≤Week 12
|
1 Participants
|
0 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : ≤Week 1
|
1 Participants
|
2 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 1 and ≤Week 2
|
2 Participants
|
0 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 2 and ≤Week 3
|
2 Participants
|
2 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 3 and ≤Week 4
|
6 Participants
|
5 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 4 and ≤Week 6
|
8 Participants
|
7 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 6 and ≤Week 8
|
5 Participants
|
8 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 8 and ≤Week 10
|
4 Participants
|
7 Participants
|
|
Participants Having Spironolactone Titrations Over Time
Down : >Week 10 and ≤Week 12
|
3 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 10Population: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
QD: Once daily QOD: Once every other day
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 1
|
0 Participants
|
0 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 2
|
0 Participants
|
0 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 3
|
86 Participants
|
76 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 4
|
105 Participants
|
94 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 6
|
106 Participants
|
96 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 8
|
106 Participants
|
85 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
50 mg QD : Week 10
|
106 Participants
|
80 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Baseline
|
147 Participants
|
148 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 1
|
145 Participants
|
144 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 2
|
140 Participants
|
142 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 3
|
49 Participants
|
57 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 4
|
27 Participants
|
34 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 6
|
25 Participants
|
28 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 8
|
26 Participants
|
24 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QD : Week 10
|
19 Participants
|
20 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 1
|
1 Participants
|
2 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 2
|
3 Participants
|
1 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 3
|
3 Participants
|
2 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 4
|
3 Participants
|
3 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 6
|
2 Participants
|
2 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 8
|
1 Participants
|
4 Participants
|
|
Number of Participants by Spironolactone Dose Prescribed at Each Visit
25 mg QOD : Week 10
|
2 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to End of Treatment, up to 12 weeks.Population: Safety Population
The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment
Outcome measures
| Measure |
Group 1 - Patiromer
n=146 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=147 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value <LLN : EoT Value<LLN
|
9 participants
|
4 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value <LLN : EoT Value Normal
|
3 participants
|
8 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value <LLN : EoT Value >ULN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value Normal : EoT Value <LLN
|
12 participants
|
7 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium- Baseline Value Normal: EoT Value Normal
|
103 participants
|
109 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value Normal : EoT Value >ULN
|
6 participants
|
10 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value >ULN : EoT Value <LLN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value >ULN : EoT Value Normal
|
10 participants
|
6 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Magnesium - Baseline Value >ULN : EoT Value >ULN
|
3 participants
|
3 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value <LLN : EoT Value <LLN
|
0 participants
|
1 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value <LLN : EoT Value Normal
|
1 participants
|
3 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value <LLN : EoT Value >ULN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value Normal : EoT Value <LLN
|
0 participants
|
1 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate- Baseline Value Normal: EoT Value Normal
|
136 participants
|
125 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value Normal : EoT Value >ULN
|
2 participants
|
8 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value >ULN : EoT Value <LLN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value >ULN : EoT Value Normal
|
5 participants
|
4 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Phosphate - Baseline Value >ULN : EoT Value >ULN
|
2 participants
|
5 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value <LLN : EoT Value <LLN
|
2 participants
|
4 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value <LLN : EoT Value Normal
|
5 participants
|
1 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value <LLN : EoT Value >ULN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value Normal : EoT Value <LLN
|
4 participants
|
6 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value Normal : EoT Value Normal
|
133 participants
|
133 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value Normal : EoT Value >ULN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value >ULN : EoT Value <LLN
|
0 participants
|
0 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value >ULN : EoT Value Normal
|
2 participants
|
1 participants
|
|
Shifts in Selected Laboratory Tests From Baseline to End of Treatment
Calcium - Baseline Value >ULN : EoT Value >ULN
|
0 participants
|
2 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 Weeks of Study TreatmentPopulation: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
Row title: Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment.
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Spironolactone Dose Level at End of 12 Weeks of Study Treatment
Participants not completing 12W of study treatment
|
21 Participants
|
50 Participants
|
|
Spironolactone Dose Level at End of 12 Weeks of Study Treatment
50 mg QD
|
102 Participants
|
76 Participants
|
|
Spironolactone Dose Level at End of 12 Weeks of Study Treatment
25 mg QD
|
22 Participants
|
19 Participants
|
|
Spironolactone Dose Level at End of 12 Weeks of Study Treatment
25 mg QOD
|
2 Participants
|
3 Participants
|
POST_HOC outcome
Timeframe: From baseline to Week 12/Early Termination visitPopulation: Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.
Row Titles: * AM: Antihypertensive Medication(s) * New AM: Participants who required additional new antihypertensive medication(s) * Increases to baseline AM: Participants who required increases to baseline antihypertensive medication(s) * Addition new (or increase) AM: Participants who required addition of new antihypertensive medication(s) and/or increases to baseline antihypertensive medications * At any time during the study: During study * While on study medication: On medication
Outcome measures
| Measure |
Group 1 - Patiromer
n=147 Participants
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 Participants
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
New AM : At any time during the study
|
0 participants
|
3 participants
|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
New AM : On medication
|
0 participants
|
1 participants
|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
Increases to baseline AM: During study
|
0 participants
|
2 participants
|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
Increases to baseline AM: On medication
|
0 participants
|
1 participants
|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
Addition new (or increases) AM: During study
|
0 participants
|
4 participants
|
|
Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications
Addition new (or increases) AM : On medication
|
0 participants
|
2 participants
|
Adverse Events
Group 1 - Patiromer
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Group 2 - Placebo
Serious events: 4 serious events
Other events: 48 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1 - Patiromer
n=147 participants at risk
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 participants at risk
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
0.68%
1/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
0.68%
1/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
0.68%
1/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.68%
1/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
0.00%
0/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
0.68%
1/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
Other adverse events
| Measure |
Group 1 - Patiromer
n=147 participants at risk
Spironolactone + blinded patiromer
Patiromer: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
Group 2 - Placebo
n=148 participants at risk
Spironolactone + blinded placebo
Placebo: 2 packets/day starting dose, administered orally
Spironolactone: 25 mg tablet/day starting dose, administered orally
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
9/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
5.4%
8/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Renal and urinary disorders
Renal impairment
|
8.8%
13/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
6.8%
10/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
7/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
8.8%
13/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Nervous system disorders
Headache
|
6.1%
9/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
7.4%
11/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
|
Vascular disorders
Hypotension
|
6.1%
9/147 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
4.1%
6/148 • During Treatment Period (12 weeks); until Follow-up Visit 2 weeks after the Week 12 Visit (or Early Termination Visit).
|
Additional Information
Clinical Support & Regulatory Intelligence, Regulatory Affairs Director
Vifor Pharma Inc.
Phone: +1 250 708 4296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 1. No Confidential Information will be disclosed, excluding CT results from Institution 2. No publication shall be initiated by PI until: * 18 months after the conclusion of the Study, defined as the locking of the clinical database * the publication of a Multicenter Publication (publication of results from all participating sites) * written notice from Sponsor that no Multicenter Publication shall ensue 3. PI shall provide a draft of proposed publication for review at least 60 days in advance
- Publication restrictions are in place
Restriction type: OTHER