Trial Outcomes & Findings for A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (NCT NCT01074125)
NCT ID: NCT01074125
Last Updated: 2014-12-04
Results Overview
Mean change from baseline was calculated separately for each treatment arm (LOCF)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
154 participants
Primary outcome timeframe
Baseline and day 28
Results posted on
2014-12-04
Participant Flow
3 patients were randomized, but withdrew before initiating study treatment
Participant milestones
| Measure |
1 g/Day
1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
6 g/Day
6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
8 g/Day
8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
48
|
|
Overall Study
COMPLETED
|
39
|
47
|
36
|
|
Overall Study
NOT COMPLETED
|
12
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Baseline characteristics by cohort
| Measure |
1 g/Day
n=50 Participants
1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
6 g/Day
n=51 Participants
6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
8 g/Day
n=45 Participants
8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
|
Total
n=146 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
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
49 participants
n=7 Participants
|
42 participants
n=5 Participants
|
138 participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and day 28Population: Intent to Treat (ITT) Population
Mean change from baseline was calculated separately for each treatment arm (LOCF)
Outcome measures
| Measure |
1 g/Day
n=50 Participants
1 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
6 g/Day
n=51 Participants
6 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
8 g/Day
n=45 Participants
8 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
|---|---|---|---|
|
Change in Serum Phosphorus From Baseline to End of Treatment
|
-0.10 mg/dL
Standard Deviation 1.285
|
-1.86 mg/dL
Standard Deviation 1.692
|
-2.13 mg/dL
Standard Deviation 1.998
|
SECONDARY outcome
Timeframe: Baseline and day 28Population: Intent-to-Treat, includes only subjects that had both baseline and end of study actual values
Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.
Outcome measures
| Measure |
1 g/Day
n=38 Participants
1 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
6 g/Day
n=44 Participants
6 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
8 g/Day
n=34 Participants
8 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
|---|---|---|---|
|
Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
|
0.04 mg/dL
Standard Deviation 1.320
|
-1.94 mg/dL
Standard Deviation 1.813
|
-2.21 mg/dL
Standard Deviation 2.097
|
SECONDARY outcome
Timeframe: Baseline and day 28Population: Intent-to-Treat
proportion was calculated separately for each treatment arm
Outcome measures
| Measure |
1 g/Day
n=50 Participants
1 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
6 g/Day
n=51 Participants
6 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
8 g/Day
n=45 Participants
8 g/day KRX-0502 (ferric citrate)
ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
|
|---|---|---|---|
|
Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
|
12.0 % of Participants
|
51.0 % of Participants
|
57.8 % of Participants
|
Adverse Events
1g/Day
Serious events: 6 serious events
Other events: 34 other events
Deaths: 0 deaths
6g/Day
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
8g/Day
Serious events: 9 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1g/Day
n=51 participants at risk
Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
6g/Day
n=52 participants at risk
Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
8g/Day
n=48 participants at risk
Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
|---|---|---|---|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Vascular disorders
Hypertension
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Vascular disorders
Hypertensive emergency
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Vascular disorders
Hypotension
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Cellulitis
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Device related infection
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Subcutaneous absess
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Cardiac disorders
Cardiac failure congestive
|
3.9%
2/51 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Cardiac disorders
Hypertensive heart disease
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypotension
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Odema
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Surgical and medical procedures
Renal transplant
|
3.9%
2/51 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
General disorders
Oedema peripheral
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
Other adverse events
| Measure |
1g/Day
n=51 participants at risk
Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
6g/Day
n=52 participants at risk
Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
8g/Day
n=48 participants at risk
Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
19.6%
10/51 • Number of events 10 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
11.5%
6/52 • Number of events 6 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
27.1%
13/48 • Number of events 13 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Faeces discoloured
|
19.6%
10/51 • Number of events 10 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
23.1%
12/52 • Number of events 12 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
14.6%
7/48 • Number of events 7 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
5.8%
3/52 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
10.4%
5/48 • Number of events 5 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Constipation
|
3.9%
2/51 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
6.2%
3/48 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
General disorders
Oedema peripheral
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
5.8%
3/52 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
3/51 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
3.8%
2/52 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
7.7%
4/52 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
5.8%
3/52 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
4.2%
2/48 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
2.1%
1/48 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
6.2%
3/48 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
11.5%
6/52 • Number of events 6 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
18.8%
9/48 • Number of events 9 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
3.8%
2/52 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Nervous system disorders
Headache
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
1.9%
1/52 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
8.3%
4/48 • Number of events 4 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/52 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
10.4%
5/48 • Number of events 5 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Vascular disorders
Hypotension
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
3.8%
2/52 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
6.2%
3/48 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/51 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
3.8%
2/52 • Number of events 2 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
6.2%
3/48 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Number of events 1 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
5.8%
3/52 • Number of events 3 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
0.00%
0/48 • Serious Adverse Events (AEs) were recorded up to 30 days post therapy
|
Additional Information
Medical Information
Keryx Biopharmaceuticals Inc
Phone: 1-844-44-KERYX (1-844-445-3799
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place