Trial Outcomes & Findings for KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD (NCT NCT02268994)
NCT ID: NCT02268994
Last Updated: 2018-03-22
Results Overview
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
Week 16
Results posted on
2018-03-22
Participant Flow
1 randomized subject was excluded because they did not receive study drug and were excluded from the safety population.
Participant milestones
| Measure |
KRX-0502 (Ferric Citrate)
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
116
|
|
Overall Study
COMPLETED
|
86
|
81
|
|
Overall Study
NOT COMPLETED
|
31
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Baseline characteristics by cohort
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=116 Participants
Matching Placebo
Placebo: Matching placebo
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
38 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 16Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
|
61 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline
|
0.39 g/dL
Standard Error 0.054
|
-0.14 g/dL
Standard Error 0.056
|
SECONDARY outcome
Timeframe: Baseline and week 16The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline
|
10.9 % saturation
Standard Error 0.65
|
-1.3 % saturation
Standard Error 0.67
|
SECONDARY outcome
Timeframe: Baseline and week 16The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Mean Change in Ferritin at the End of 16 Weeks Minus Baseline
|
68.1 ng/mL
Standard Error 3.99
|
-6.1 ng/mL
Standard Error 4.10
|
SECONDARY outcome
Timeframe: Week 16Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)
|
57 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline and week 16The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.
Outcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=117 Participants
1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=115 Participants
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline
|
-0.28 mg/dL
Standard Error 0.036
|
-0.14 mg/dL
Standard Error 0.037
|
Adverse Events
KRX-0502 (Ferric Citrate)
Serious events: 14 serious events
Other events: 61 other events
Deaths: 2 deaths
Placebo
Serious events: 13 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KRX-0502 (Ferric Citrate)
n=117 participants at risk
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=116 participants at risk
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Cardiac Arrest
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/117 • 16 Week Randomized Period
|
1.7%
2/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Dysphagia
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
General disorders
Necrosis
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Infections and infestations
Pneumonia
|
1.7%
2/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Infections and infestations
Clostridium Difficle Colitis
|
0.85%
1/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Infections and infestations
Sepsis
|
0.85%
1/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Infections and infestations
Abscess Limb
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Infections and infestations
Diverticulitis
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Infections and infestations
Septic Shock
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Infections and infestations
Celluitis
|
0.00%
0/117 • 16 Week Randomized Period
|
1.7%
2/116 • 16 Week Randomized Period
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Investigations
Blood Glucose Increased
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
2/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Nervous system disorders
Metabolic Encephalopathy
|
1.7%
2/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Nervous system disorders
Status Epilepticus
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Nervous system disorders
Syncope
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.6%
3/117 • 16 Week Randomized Period
|
1.7%
2/116 • 16 Week Randomized Period
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.85%
1/117 • 16 Week Randomized Period
|
1.7%
2/116 • 16 Week Randomized Period
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
2.6%
3/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/117 • 16 Week Randomized Period
|
0.86%
1/116 • 16 Week Randomized Period
|
|
Surgical and medical procedures
Toe Amputation
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Vascular disorders
Hypertension
|
0.85%
1/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
Other adverse events
| Measure |
KRX-0502 (Ferric Citrate)
n=117 participants at risk
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron
|
Placebo
n=116 participants at risk
Matching Placebo
Placebo: Matching placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
20.5%
24/117 • 16 Week Randomized Period
|
16.4%
19/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Constipation
|
18.8%
22/117 • 16 Week Randomized Period
|
12.9%
15/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Faeces Discoloured
|
14.5%
17/117 • 16 Week Randomized Period
|
0.00%
0/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Nausea
|
11.1%
13/117 • 16 Week Randomized Period
|
2.6%
3/116 • 16 Week Randomized Period
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.0%
7/117 • 16 Week Randomized Period
|
1.7%
2/116 • 16 Week Randomized Period
|
|
General disorders
Fatigue
|
0.00%
0/117 • 16 Week Randomized Period
|
5.2%
6/116 • 16 Week Randomized Period
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.8%
8/117 • 16 Week Randomized Period
|
3.4%
4/116 • 16 Week Randomized Period
|
|
Vascular disorders
Hypertension
|
4.3%
5/117 • 16 Week Randomized Period
|
5.2%
6/116 • 16 Week Randomized Period
|
Additional Information
Keryx Medical Information
Keryx Biopharmaceuticals, Inc.
Phone: 1-844-44-KERYX (844-445-3799)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60