Trial Outcomes & Findings for Study of Phosphate Levels in Patients With Chronic Kidney Disease (NCT NCT00824460)
NCT ID: NCT00824460
Last Updated: 2014-04-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
6 weeks after baseline
Results posted on
2014-04-01
Participant Flow
Participant milestones
| Measure |
1.25 g PA21 (250 mg Iron)
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5 g PA21 (2,500 mg Iron)
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
25
|
27
|
24
|
26
|
|
Overall Study
COMPLETED
|
18
|
17
|
20
|
15
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
5
|
12
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
1.25 g PA21 (250 mg Iron)
n=26 Participants
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=26 Participants
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=25 Participants
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=27 Participants
Daily dose of 10.0g PA21 (8 tablets)
|
12.5g PA21 (2,500 mg Iron)
n=24 Participants
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=26 Participants
Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
|
Total
n=154 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
93 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
61 Participants
n=115 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 12.29 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 13.80 • n=7 Participants
|
61.9 years
STANDARD_DEVIATION 13.71 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 12.74 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 12.32 • n=21 Participants
|
61.1 years
STANDARD_DEVIATION 11.00 • n=10 Participants
|
60.5 years
STANDARD_DEVIATION 12.50 • n=115 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
57 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
15 Participants
n=10 Participants
|
97 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
21 participants
n=115 Participants
|
|
Region of Enrollment
Czech Republic
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=10 Participants
|
8 participants
n=115 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=10 Participants
|
15 participants
n=115 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Region of Enrollment
Croatia
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
7 participants
n=10 Participants
|
40 participants
n=115 Participants
|
|
Region of Enrollment
Russian Federation
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=10 Participants
|
28 participants
n=115 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
7 participants
n=21 Participants
|
1 participants
n=10 Participants
|
23 participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
5 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 6 weeks after baselinePopulation: For the Primary Outcome, data from the Full Analysis Set (FAS) was used. The FAS consists of all randomised subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).
Outcome measures
| Measure |
1.25 g PA21 (250 mg Iron)
n=26 Participants
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=26 Participants
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=25 Participants
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=25 Participants
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5g PA21 (2,500 mg Iron)
n=24 Participants
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=24 Participants
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
|
-0.042 mmol/L
Standard Deviation 0.650
|
-0.348 mmol/L
Standard Deviation 0.684
|
-0.404 mmol/L
Standard Deviation 0.391
|
-0.644 mmol/L
Standard Deviation 0.551
|
-0.547 mmol/L
Standard Deviation 0.584
|
-0.341 mmol/L
Standard Deviation 0.436
|
SECONDARY outcome
Timeframe: 2 weeks after baselinePopulation: For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment). Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2.
Outcome measures
| Measure |
1.25 g PA21 (250 mg Iron)
n=26 Participants
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=26 Participants
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=25 Participants
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=24 Participants
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5g PA21 (2,500 mg Iron)
n=24 Participants
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=24 Participants
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum-phosphate Levels at Week 2
|
-0.03 mmol/L
Standard Deviation 0.55
|
-0.36 mmol/L
Standard Deviation 0.35
|
-0.41 mmol/L
Standard Deviation 0.40
|
-0.47 mmol/L
Standard Deviation 0.62
|
-0.46 mmol/L
Standard Deviation 0.45
|
-0.41 mmol/L
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 4 weeks after baselinePopulation: For this Secondary Outcome, FAS was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment). Number of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4.
Outcome measures
| Measure |
1.25 g PA21 (250 mg Iron)
n=24 Participants
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=23 Participants
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=22 Participants
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=21 Participants
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5g PA21 (2,500 mg Iron)
n=21 Participants
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=22 Participants
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum-phosphate Levels at Week 4
|
-0.03 mmol/L
Standard Deviation 0.39
|
-0.39 mmol/L
Standard Deviation 0.45
|
-0.32 mmol/L
Standard Deviation 0.54
|
-0.58 mmol/L
Standard Deviation 0.53
|
-0.53 mmol/L
Standard Deviation 0.48
|
-0.53 mmol/L
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: 5 weeks after baselinePopulation: For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment). Number of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5.
Outcome measures
| Measure |
1.25 g PA21 (250 mg Iron)
n=24 Participants
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=21 Participants
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=21 Participants
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=19 Participants
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5g PA21 (2,500 mg Iron)
n=20 Participants
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=20 Participants
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Serum-phosphate Levels at Week 5
|
-0.05 mmol/L
Standard Deviation 0.62
|
-0.51 mmol/L
Standard Deviation 0.62
|
-0.40 mmol/L
Standard Deviation 0.33
|
-0.57 mmol/L
Standard Deviation 0.55
|
-0.58 mmol/L
Standard Deviation 0.58
|
-0.52 mmol/L
Standard Deviation 0.37
|
Adverse Events
1.25 g PA21 (250 mg Iron)
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
5.0 g PA21 (1,000 mg Iron)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
7.5 g PA21 (1,500 mg Iron)
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
10.0 g PA21 (2,000 mg Iron)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
12.5 g PA21 (2,500 mg Iron)
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Sevelamer Hydrochloride - Active Control
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.25 g PA21 (250 mg Iron)
n=26 participants at risk
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=26 participants at risk
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=25 participants at risk
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=27 participants at risk
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5 g PA21 (2,500 mg Iron)
n=24 participants at risk
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=26 participants at risk
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.2%
1/24 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.0%
1/25 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.2%
1/24 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26 • Number of events 1
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
1.25 g PA21 (250 mg Iron)
n=26 participants at risk
Daily dose of 1.25 g PA21 (1 tablet)
|
5.0 g PA21 (1,000 mg Iron)
n=26 participants at risk
Daily dose of 5.0 g PA21 (4 tablets)
|
7.5 g PA21 (1,500 mg Iron)
n=25 participants at risk
Daily dose of 7.5 g PA21 (6 tablets)
|
10.0 g PA21 (2,000 mg Iron)
n=27 participants at risk
Daily dose of 10.0 g PA21 (8 tablets)
|
12.5 g PA21 (2,500 mg Iron)
n=24 participants at risk
Daily dose of 12.5 g PA21 (10 tablets)
|
Sevelamer Hydrochloride - Active Control
n=26 participants at risk
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
15.4%
4/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.0%
2/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
29.6%
8/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
29.2%
7/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
15.4%
4/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
11.5%
3/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.0%
1/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.0%
1/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.2%
1/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Faeces Discoloure
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
11.5%
3/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
12.0%
3/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
14.8%
4/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
12.5%
3/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.0%
2/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.2%
1/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
4.0%
1/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.4%
2/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
7.7%
2/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.0%
2/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.7%
1/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
12.5%
3/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.0%
2/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.3%
2/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
3.8%
1/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
11.5%
3/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
8.3%
2/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
12.0%
3/25
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/27
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/24
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
0.00%
0/26
For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.
- Publication restrictions are in place
Restriction type: OTHER