Trial Outcomes & Findings for A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis (NCT NCT01191255)

NCT ID: NCT01191255

Last Updated: 2014-12-10

Results Overview

Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

441 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-12-10

Participant Flow

1. Only subjects that completed the SAP on KRX-0502 were eligible to be included in the EAP 2. in the EAP, subjects received only Placebo or KRX-0502-EAP 3. 3 Subjects switched from 'Active Control' to KRX-0502 during the SAP and were randomized into the EAP 4. In the 'Active Control' group, a combination of phosphate binders was allowed

Participant milestones

Participant milestones
Measure	Active Control-SAP Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Safety Assessment Period STARTED	149	292	0	0
Safety Assessment Period Safety Population	149	289	0	0
Safety Assessment Period COMPLETED	111	193	0	0
Safety Assessment Period NOT COMPLETED	38	99	0	0
Efficacy Assessment Period STARTED	0	0	96	96
Efficacy Assessment Period COMPLETED	0	0	70	90
Efficacy Assessment Period NOT COMPLETED	0	0	26	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Control-SAP n=146 Participants Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP n=281 Participants Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP n=91 Participants Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP n=91 Participants Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Total n=609 Participants Total of all reporting groups
Age, Customized Age <65 years (SAP)	118 participants n=5 Participants	223 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	341 participants n=21 Participants
Age, Customized Age >= 65 years (SAP)	28 participants n=5 Participants	58 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	86 participants n=21 Participants
Age, Customized Age <65 years (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	77 participants n=5 Participants	73 participants n=4 Participants	150 participants n=21 Participants
Age, Customized Age >= 65 years (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	14 participants n=5 Participants	18 participants n=4 Participants	32 participants n=21 Participants
Sex/Gender, Customized Female (SAP)	62 participants n=5 Participants	106 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	168 participants n=21 Participants
Sex/Gender, Customized Male (SAP)	84 participants n=5 Participants	175 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	259 participants n=21 Participants
Sex/Gender, Customized Female (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	77 participants n=5 Participants	73 participants n=4 Participants	150 participants n=21 Participants
Sex/Gender, Customized Male (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	14 participants n=5 Participants	18 participants n=4 Participants	32 participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino (SAP)	23 participants n=5 Participants	41 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	64 participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino (SAP)	123 participants n=5 Participants	239 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	362 participants n=21 Participants
Race/Ethnicity, Customized Unknown or not reported (SAP)	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	14 participants n=5 Participants	9 participants n=4 Participants	23 participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	77 participants n=5 Participants	82 participants n=4 Participants	159 participants n=21 Participants
Race/Ethnicity, Customized Unknown or not reported (EAP)	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
Race/Ethnicity, Customized American Indian or Alaska Native (SAP)	1 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Asian (SAP)	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander (SAP)	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Black or African American (SAP)	77 participants n=5 Participants	153 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	230 participants n=21 Participants
Race/Ethnicity, Customized White (SAP)	61 participants n=5 Participants	114 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	175 participants n=21 Participants
Race/Ethnicity, Customized More Than One Race (SAP)	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported (SAP)	4 participants n=5 Participants	11 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	15 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Asian (EAP)	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
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander (EAP)	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
Race/Ethnicity, Customized Black or African American (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	48 participants n=5 Participants	59 participants n=4 Participants	107 participants n=21 Participants
Race/Ethnicity, Customized White (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	39 participants n=5 Participants	28 participants n=4 Participants	67 participants n=21 Participants
Race/Ethnicity, Customized More Than One Race (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported (EAP)	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Full Analysis Population (LOCF)

Patients who completed the 52-week Safety Assessment Period (SAP) on KRX-0502 (ferric citrate) were randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or Placebo for 4 weeks.

Outcome measures

Outcome measures
Measure	Active Control-SAP Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP n=91 Participants Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP n=91 Participants Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) Baseline (Week 52)	—	—	5.44 mg/dL Standard Deviation 1.459	5.12 mg/dL Standard Deviation 1.189
Change in Mean Serum Phosphorus From Baseline (Week 52) to the End of the Efficacy Assessment Period (EAP; Week 56) End of EAP (Week 56)	—	—	7.23 mg/dL Standard Deviation 1.784	4.89 mg/dL Standard Deviation 1.291

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Population (LOCF)

Outcome measures

Outcome measures
Measure	Active Control-SAP n=137 Participants Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP n=253 Participants Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Change in Mean Serum Ferritin From Baseline to Week 52 Baseline	609.50 ng/mL Standard Deviation 307.689	592.80 ng/mL Standard Deviation 292.863	—	—
Change in Mean Serum Ferritin From Baseline to Week 52 End of SAP (Week 52)	631.87 ng/mL Standard Deviation 368.919	894.88 ng/mL Standard Deviation 481.788	—	—

SECONDARY outcome

Timeframe: 52 weeks

Population: Full Analysis Population (LOCF)

Outcome measures

Outcome measures
Measure	Active Control-SAP n=137 Participants Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP n=252 Participants Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) Baseline	30.8 % Saturation Standard Deviation 11.57	31.3 % Saturation Standard Deviation 11.21	—	—
Change in Mean Serum Transferrin Saturation (TSAT) From Baseline to the End of the Safety Assessment Period (Week 52) End of SAP (Week 52)	29.7 % Saturation Standard Deviation 11.43	39.2 % Saturation Standard Deviation 16.78	—	—

SECONDARY outcome

Timeframe: 52 weeks

Full Analysis Population, cumulative IV Iron administration from Baseline to the end of the Safety Assessment Period (Week 52)

Outcome measures

Outcome measures
Measure	Active Control-SAP n=138 Participants Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP n=271 Participants Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
IV Iron Analysis	3.83 mg/day Interval 0.0 to 43.6	1.87 mg/day Interval 0.0 to 24.2	—	—

SECONDARY outcome

Timeframe: 52 weeks

Full analysis population, cumulative Erythropoiesis-stimulating agent (ESA) administration from baseline to the end of the Safety Assessment Period (Week 52)

Outcome measures

Outcome measures
Measure	Active Control-SAP n=141 Participants Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.	KRX-0502 (Ferric Citrate)-SAP n=273 Participants Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period. Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	Placebo-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.	KRX-0502 (Ferric Citrate)-EAP Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
ESA Analysis	993.46 Units/Day Interval 0.0 to 11015.0	755.80 Units/Day Interval 0.0 to 8171.9	—	—

Adverse Events

KRX-0502 (SAP)

Serious events: 114 serious events

Other events: 211 other events

Deaths: 0 deaths

Active Control (SAP)

Serious events: 73 serious events

Other events: 88 other events

Deaths: 0 deaths

KRX-0502 (EAP)

Serious events: 11 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo (EAP)

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	KRX-0502 (SAP) n=289 participants at risk Safety Assessment Period (Week 1-52)	Active Control (SAP) n=149 participants at risk Safety Assessment Period (Week 1-52)	KRX-0502 (EAP) n=95 participants at risk Efficacy Assessment Period (Week 52-56)	Placebo (EAP) n=95 participants at risk Efficacy Assessment Period (Week 52-56)
Cardiac disorders Dyspnea	3.5% 10/289 • Number of events 10 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	7.4% 11/149 • Number of events 11 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Abdominal pain	4.8% 14/289 • Number of events 14 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.7% 7/149 • Number of events 7 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Constipation	7.3% 21/289 • Number of events 21 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.0% 6/149 • Number of events 6 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Diarrhea	24.9% 72/289 • Number of events 72 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	12.8% 19/149 • Number of events 19 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Feces discolored	17.0% 49/289 • Number of events 49 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/149 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Nausea	13.1% 38/289 • Number of events 38 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	12.1% 18/149 • Number of events 18 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Gastrointestinal disorders Vomiting	8.3% 24/289 • Number of events 24 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	12.1% 18/149 • Number of events 18 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
General disorders Chest pain	5.2% 15/289 • Number of events 15 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.0% 6/149 • Number of events 6 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
General disorders Edema peripheral	3.1% 9/289 • Number of events 9 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	5.4% 8/149 • Number of events 8 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
General disorders Pyrexia	3.1% 9/289 • Number of events 9 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.7% 7/149 • Number of events 7 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Infections and infestations Nasopharyngitis	7.3% 21/289 • Number of events 21 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	6.0% 9/149 • Number of events 9 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Injury, poisoning and procedural complications Arteriovenous fistula site complication	4.2% 12/289 • Number of events 12 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	5.4% 8/149 • Number of events 8 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Injury, poisoning and procedural complications Vascular access complication	8.0% 23/289 • Number of events 23 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	9.4% 14/149 • Number of events 14 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	5.3% 5/95 • Number of events 5 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Metabolism and nutrition disorders Decreased appetite	5.2% 15/289 • Number of events 15 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	3.4% 5/149 • Number of events 5 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Metabolism and nutrition disorders Hyperkalemia	2.8% 8/289 • Number of events 8 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	6.0% 9/149 • Number of events 9 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	2.4% 7/289 • Number of events 7 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.7% 7/149 • Number of events 7 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Pain in extremity	5.2% 15/289 • Number of events 15 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	9.4% 14/149 • Number of events 14 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Nervous system disorders Dizziness	4.8% 14/289 • Number of events 14 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	6.7% 10/149 • Number of events 10 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Nervous system disorders Headache	7.6% 22/289 • Number of events 22 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	7.4% 11/149 • Number of events 11 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	9.0% 26/289 • Number of events 26 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	10.1% 15/149 • Number of events 15 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Dyspnea	4.2% 12/289 • Number of events 12 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	4.7% 7/149 • Number of events 7 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Skin and subcutaneous tissue disorders Pruritus	4.8% 14/289 • Number of events 14 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	6.7% 10/149 • Number of events 10 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Hypotension	5.2% 15/289 • Number of events 15 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	8.1% 12/149 • Number of events 12 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug	0.00% 0/95 • Serious treatement emergent adverse events (TEAEs) up to 56 weeks Safety Population, includes all patients that took at least 1 dose of study drug