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Trial record 49 of 380 for:    FERRIC CATION

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

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ClinicalTrials.gov Identifier: NCT01074125
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hyperphosphatemia
End-Stage Renal Disease
Intervention Drug: ferric citrate
Enrollment 154
Recruitment Details  
Pre-assignment Details 3 patients were randomized, but withdrew before initiating study treatment
Arm/Group Title 1 g/Day 6 g/Day 8 g/Day
Hide Arm/Group Description 1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days 6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days 8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
Period Title: Overall Study
Started 51 52 48
Completed 39 47 36
Not Completed 12 5 12
Arm/Group Title 1 g/Day 6 g/Day 8 g/Day Total
Hide Arm/Group Description 1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days 6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days 8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days Total of all reporting groups
Overall Number of Baseline Participants 50 51 45 146
Hide Baseline Analysis Population Description
Intent-to-treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 45 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  78.0%
37
  72.5%
39
  86.7%
115
  78.8%
>=65 years
11
  22.0%
14
  27.5%
6
  13.3%
31
  21.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 45 participants 146 participants
Female
18
  36.0%
21
  41.2%
19
  42.2%
58
  39.7%
Male
32
  64.0%
30
  58.8%
26
  57.8%
88
  60.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 45 participants 146 participants
United States 47 49 42 138
Puerto Rico 3 2 3 8
1.Primary Outcome
Title Change in Serum Phosphorus From Baseline to End of Treatment
Hide Description Mean change from baseline was calculated separately for each treatment arm (LOCF)
Time Frame Baseline and day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population
Arm/Group Title 1 g/Day 6 g/Day 8 g/Day
Hide Arm/Group Description:

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 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 KRX-0502 (ferric citrate)

ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Overall Number of Participants Analyzed 50 51 45
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.10  (1.285) -1.86  (1.692) -2.13  (1.998)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 g/Day, 6 g/Day, 8 g/Day
Comments To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3376
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment
Hide Description 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.
Time Frame Baseline and day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat, includes only subjects that had both baseline and end of study actual values
Arm/Group Title 1 g/Day 6 g/Day 8 g/Day
Hide Arm/Group Description:
1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
Overall Number of Participants Analyzed 38 44 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.04  (1.320) -1.94  (1.813) -2.21  (2.097)
3.Secondary Outcome
Title Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment
Hide Description proportion was calculated separately for each treatment arm
Time Frame Baseline and day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title 1 g/Day 6 g/Day 8 g/Day
Hide Arm/Group Description:

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 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 KRX-0502 (ferric citrate)

ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Overall Number of Participants Analyzed 50 51 45
Measure Type: Number
Unit of Measure: % of Participants
12.0 51.0 57.8
Time Frame Serious Adverse Events (AEs) were recorded up to 30 days post therapy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1g/Day 6g/Day 8g/Day
Hide Arm/Group Description Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
All-Cause Mortality
1g/Day 6g/Day 8g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1g/Day 6g/Day 8g/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/51 (11.76%)      7/52 (13.46%)      9/48 (18.75%)    
Blood and lymphatic system disorders       
Anaemia  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Cardiac disorders       
Cardiac failure congestive  1  2/51 (3.92%)  2 0/52 (0.00%)  0 0/48 (0.00%)  0
Acute myocardial infarction  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Hypertensive heart disease  1  1/51 (1.96%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0
Gastrointestinal disorders       
Haematemesis  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Umbilical hernia, obstructive  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
General disorders       
Oedema peripheral  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Infections and infestations       
Bacteraemia  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Cellulitis  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Device related infection  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Pneumonia  1  1/51 (1.96%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0
Subcutaneous absess  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Injury, poisoning and procedural complications       
Arteriovenous fistula aneurysm  1  1/51 (1.96%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0
Investigations       
Blood glucose fluctuation  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Metabolism and nutrition disorders       
Hyperkalaemia  1  0/51 (0.00%)  0 1/52 (1.92%)  1 1/48 (2.08%)  1
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/51 (0.00%)  0 1/52 (1.92%)  1 1/48 (2.08%)  1
Nervous system disorders       
Cerebral haemorrhage  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Haemorrhage intracranial  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Syncope  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Renal and urinary disorders       
Azotaemia  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Hypoxia  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Pulmonary Hypotension  1  0/51 (0.00%)  1/52 (1.92%)  1 0/48 (0.00%)  0
Pulmonary Odema  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Surgical and medical procedures       
Renal transplant  1  2/51 (3.92%)  2 0/52 (0.00%)  0 0/48 (0.00%)  0
Vascular disorders       
Hypertensive crisis  1  1/51 (1.96%)  1 0/52 (0.00%)  0 1/48 (2.08%)  1
Hypertension  1  0/51 (0.00%)  0 0/52 (0.00%)  0 1/48 (2.08%)  1
Hypertensive emergency  1  1/51 (1.96%)  1 0/52 (0.00%)  0 0/48 (0.00%)  0
Hypotension  1  0/51 (0.00%)  0 1/52 (1.92%)  1 0/48 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1g/Day 6g/Day 8g/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/51 (66.67%)      43/52 (82.69%)      41/48 (85.42%)    
Gastrointestinal disorders       
Diarrhoea  1  10/51 (19.61%)  10 6/52 (11.54%)  6 13/48 (27.08%)  13
Faeces discoloured  1  10/51 (19.61%)  10 12/52 (23.08%)  12 7/48 (14.58%)  7
Nausea  1  4/51 (7.84%)  4 3/52 (5.77%)  3 5/48 (10.42%)  5
Constipation  1  2/51 (3.92%)  2 1/52 (1.92%)  1 4/48 (8.33%)  4
Vomiting  1  3/51 (5.88%)  3 1/52 (1.92%)  1 3/48 (6.25%)  3
Abdominal pain upper  1  0/51 (0.00%)  0 1/52 (1.92%)  1 4/48 (8.33%)  4
General disorders       
Oedema peripheral  1  1/51 (1.96%)  1 3/52 (5.77%)  3 1/48 (2.08%)  1
Infections and infestations       
Upper respiratory tract infection  1  1/51 (1.96%)  1 0/52 (0.00%)  0 4/48 (8.33%)  4
Injury, poisoning and procedural complications       
Fall  1  3/51 (5.88%)  3 2/52 (3.85%)  2 0/48 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  0/51 (0.00%)  0 0/52 (0.00%)  0 3/48 (6.25%)  3
Hypocalcaemia  1  1/51 (1.96%)  1 6/52 (11.54%)  6 9/48 (18.75%)  9
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/51 (0.00%)  0 4/52 (7.69%)  4 4/48 (8.33%)  4
Muscle spasms  1  0/51 (0.00%)  0 3/52 (5.77%)  3 2/48 (4.17%)  2
Arthralgia  1  3/51 (5.88%)  3 0/52 (0.00%)  0 1/48 (2.08%)  1
Nervous system disorders       
Dizziness  1  0/51 (0.00%)  0 2/52 (3.85%)  2 4/48 (8.33%)  4
Headache  1  0/51 (0.00%)  0 1/52 (1.92%)  1 4/48 (8.33%)  4
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/51 (0.00%)  0 2/52 (3.85%)  2 3/48 (6.25%)  3
Skin and subcutaneous tissue disorders       
Pruritus  1  1/51 (1.96%)  1 3/52 (5.77%)  3 0/48 (0.00%)  0
Vascular disorders       
Hypertension  1  2/51 (3.92%)  2 0/52 (0.00%)  0 5/48 (10.42%)  5
Hypotension  1  1/51 (1.96%)  1 2/52 (3.85%)  2 3/48 (6.25%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Keryx Biopharmaceuticals Inc
Phone: 1-844-44-KERYX (1-844-445-3799
EMail: medicalinfo@keryx.com
Layout table for additonal information
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01074125     History of Changes
Other Study ID Numbers: KRX-0502-305
First Submitted: February 17, 2010
First Posted: February 24, 2010
Results First Submitted: October 4, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014