Trial Outcomes & Findings for Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (NCT NCT00967993)
NCT ID: NCT00967993
Last Updated: 2014-12-05
Results Overview
Recruitment status
COMPLETED
Target enrollment
22 participants
Primary outcome timeframe
4 weeks
Results posted on
2014-12-05
Participant Flow
Participant milestones
| Measure |
KRX-0502
All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease
Baseline characteristics by cohort
| Measure |
KRX-0502
n=22 Participants
All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
KRX-0502 (Ferric Citrate)
n=19 Participants
Single arm clinical trial of KRX-0502 (ferric citrate)
|
|---|---|
|
The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period.
|
-1.53 mg/dL
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
Outcome data not reported
Adverse Events
KRX-0502 (Ferric Citrate)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
KRX-0502 (Ferric Citrate)
n=22 participants at risk
Single arm clinical trial of KRX-0502 (ferric citrate)
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
3/22 • Number of events 3
|
|
Gastrointestinal disorders
Exacerbation of Constipation
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Loose Stool Intermittent
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Odor of ferric citrate
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Clotted A-V Fistula Recurrent
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Exertion Fatigue
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Fatigue
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Strange Feeling in Head
|
4.5%
1/22 • Number of events 2
|
|
Hepatobiliary disorders
Liver Enzyme Elevation
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Hand Dysaesthsia
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Decrease in Urea Reduction Rate
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Itching
|
9.1%
2/22 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash Diffuse
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Low BP Dizziness Weakness
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Syncope
|
4.5%
1/22 • Number of events 1
|
Additional Information
Medical Information
Keryx Biopharmaceuticals Inc
Phone: 1-844-44-KERYX (1-844-445-379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place