Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Study Details
Study Description
Brief Summary
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Detailed Description
PROTOCOL SUMMARY
Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Short Title: FeCitrate
Protocol Number: KP FeCitrate
Study Phase: 4
Study Site(s): Los Angeles Kaiser Sunset Medical Center
Number of Subjects: 55
Study Arms: 1
Indication: Hyperphosphatemia in end stage renal disease
Primary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment
Overview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).
Investigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Study Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (<5.5mg/dl) 6 months before and after treatment with ferric citrate
Statistical Methods: Not powered to detect statistical significance
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Ferric Citrate Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. |
Drug: Ferric Citrate
One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Phosphorus Levels [6 months]
Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
Secondary Outcome Measures
- Intravenous (IV) Iron [6 months]
The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.
- Erythropoiesis Stimulating Agents (ESA) Dose [6 months]
Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.
- Median Pill Count [6 months]
median pill count of ferric citrate pills/day required to maintain phosphorus control
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
-
Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment
-
No allergy to iron
-
Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment
-
Mean PTH < 1000 pg/ml for 6 months prior to enrollment
-
Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment
Exclusion Criteria:
-
History of gastrointestinal bleeding within past 6 months
-
History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
-
Acute kidney injury equal to or less than 3 months before the initial screening date
-
Active malignancy
-
Functioning renal transplant
-
Patients with iron overload syndrome (e.g., Hemochromatosis)
-
History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
-
Active or past history of calciphylaxis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
Sponsors and Collaborators
- Kaiser Permanente
- Keryx Biopharmaceuticals
Investigators
- Principal Investigator: Victoria Kumar, MD, Kaiser Permanente
Study Documents (Full-Text)
More Information
Publications
None provided.- FeCitrate
- 11035
Study Results
Participant Flow
Recruitment Details | Study subjects who received either hemodialysis (HD) or peritoneal dialysis (PD) at Kaiser Permanente Southern California, Los Angeles Medical Center were eligible for recruitment. |
---|---|
Pre-assignment Detail | No pre-assignment events. 55 subjects were enrolled. |
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis |
---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. |
Period Title: Overall Study | ||
STARTED | 28 | 27 |
COMPLETED | 15 | 16 |
NOT COMPLETED | 13 | 11 |
Baseline Characteristics
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis | Total |
---|---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Total of all reporting groups |
Overall Participants | 21 | 26 | 47 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
65
(13)
|
57
(14)
|
60
(14)
|
Sex: Female, Male (Count of Participants) | |||
Female |
6
28.6%
|
7
26.9%
|
13
27.7%
|
Male |
15
71.4%
|
19
73.1%
|
34
72.3%
|
Race/Ethnicity, Customized (Count of Participants) | |||
Asian |
7
33.3%
|
6
23.1%
|
13
27.7%
|
African American |
6
28.6%
|
3
11.5%
|
9
19.1%
|
White |
7
33.3%
|
14
53.8%
|
21
44.7%
|
Unknown Race |
1
4.8%
|
3
11.5%
|
4
8.5%
|
Hispanic |
7
33.3%
|
12
46.2%
|
19
40.4%
|
Not Hispanic |
14
66.7%
|
13
50%
|
27
57.4%
|
Unknown Ethnicity |
0
0%
|
1
3.8%
|
1
2.1%
|
Region of Enrollment (participants) [Number] | |||
United States |
21
100%
|
26
100%
|
47
100%
|
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [kg/m^2] |
28.4
(4.7)
|
27.8
(5.2)
|
28.1
(4.9)
|
Smoking (Count of Participants) | |||
Count of Participants [Participants] |
10
47.6%
|
6
23.1%
|
16
34%
|
Duration on Dialysis (months) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [months] |
29
(32.1)
|
41.4
(49.2)
|
36.2
(42.5)
|
Diabetes (Count of Participants) | |||
Count of Participants [Participants] |
8
38.1%
|
7
26.9%
|
15
31.9%
|
Cerebrovascular Disease (Count of Participants) | |||
Count of Participants [Participants] |
6
28.6%
|
2
7.7%
|
8
17%
|
Congestive Heart Failure (Count of Participants) | |||
Count of Participants [Participants] |
5
23.8%
|
4
15.4%
|
9
19.1%
|
Ischemic Heart Failure (Count of Participants) | |||
Count of Participants [Participants] |
2
9.5%
|
2
7.7%
|
4
8.5%
|
Peripheral Vascular Disease (Count of Participants) | |||
Count of Participants [Participants] |
5
23.8%
|
0
0%
|
5
10.6%
|
Outcome Measures
Title | Phosphorus Levels |
---|---|
Description | Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment |
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis |
---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. |
Measure Participants | 21 | 26 |
Pre-treatment |
5.3
(1)
|
5.6
(0.8)
|
On-treatment |
5.4
(1.1)
|
6
(1.8)
|
Title | Intravenous (IV) Iron |
---|---|
Description | The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment. |
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis |
---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. |
Measure Participants | 21 | 26 |
Pre-Treatment |
249.2
(215.6)
|
21.2
(43.1)
|
On-Treatment |
102
(137.5)
|
11.6
(33.7)
|
Title | Erythropoiesis Stimulating Agents (ESA) Dose |
---|---|
Description | Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome. |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and post-treatment. |
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis |
---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. |
Measure Participants | 21 | 26 |
Pre-Treatment |
28761.1
(41314.1)
|
16724.4
(14042.3)
|
Post-Treatment |
16525.8
(16917)
|
16780.1
(13433.7)
|
Title | Median Pill Count |
---|---|
Description | median pill count of ferric citrate pills/day required to maintain phosphorus control |
Time Frame | 6 months |
Outcome Measure Data
Analysis Population Description |
---|
The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. |
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis |
---|---|---|
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. |
Measure Participants | 21 | 26 |
Phosphate binder pill count prior to Ferric Citrate use |
9.5
|
6
|
Phosphate binder pill count during Ferric Citrate use |
6.0
|
4.5
|
Adverse Events
Time Frame | 7 months | |||
---|---|---|---|---|
Adverse Event Reporting Description | Adverse event (AE's) were included for all patient who received study drug for at least 1 day (n=54). After the baseline visit adverse events are collected on a weekly basis for the hemodialysis patients, and on a bi-monthly basis from the dialysis patients, and again 30days after the termination of the study. | |||
Arm/Group Title | Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis | ||
Arm/Group Description | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles. Ferric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption. | ||
All Cause Mortality |
||||
Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/27 (0%) | 0/27 (0%) | ||
Serious Adverse Events |
||||
Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/27 (25.9%) | 10/27 (37%) | ||
Blood and lymphatic system disorders | ||||
Arteriovenous fistula | 2/27 (7.4%) | 2 | 0/27 (0%) | 0 |
Cardiac disorders | ||||
Congestive heart failure exacerbation | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Gastrointestinal disorders | ||||
gallstone pancreatitis | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Gastrointestinal Hemorrhage | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Hematochezia | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
General disorders | ||||
Abdominal swelling | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Peritonitis | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Infections and infestations | ||||
Right foot infection | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Chest pain | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Chronic back pain | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Intertrochanteric fracture | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Left foot pain | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Right hip osteoporotic Fracture | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Renal and urinary disorders | ||||
Laparoscopic right nephrectomy | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Placement of catheter for HD | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||
Pneumonia | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Right sided pleuroperitoneal leak | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Left heel ulcers | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Vascular disorders | ||||
Critical limb ischemia | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Hemorrhagic cerebrovascular accident | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 |
Peripheral vascular disease | 1/27 (3.7%) | 1 | 0/27 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Ferric Citrate - Hemodialysis | Ferric Citrate - Peritoneal Dialysis | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 23/27 (85.2%) | 27/27 (100%) | ||
Cardiac disorders | ||||
Chest Pain/Palpitations | 0/27 (0%) | 1/27 (3.7%) | ||
Gastrointestinal disorders | ||||
Black stool | 20/27 (74.1%) | 25/27 (92.6%) | ||
Diarrhea | 10/27 (37%) | 10/27 (37%) | ||
Constipation | 4/27 (14.8%) | 5/27 (18.5%) | ||
Bloating/Gas | 2/27 (7.4%) | 2/27 (7.4%) | ||
Abdominal pain | 1/27 (3.7%) | 2/27 (7.4%) | ||
Nausea, vomiting | 1/27 (3.7%) | 4/27 (14.8%) | ||
General disorders | ||||
Peritonitis | 0/27 (0%) | 1/27 (3.7%) | ||
Fatigue | 2/27 (7.4%) | 0/27 (0%) | ||
Infections and infestations | ||||
Abscess | 0/27 (0%) | 1/27 (3.7%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 0/27 (0%) | 3/27 (11.1%) | ||
Renal and urinary disorders | ||||
Urinary Tract Infection | 1/27 (3.7%) | 0/27 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Upper Respiratory Infection | 2/27 (7.4%) | 4/27 (14.8%) | ||
Skin and subcutaneous tissue disorders | ||||
Itching/rash | 2/27 (7.4%) | 4/27 (14.8%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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
Name/Title | KPSC PRS Administrator |
---|---|
Organization | Kaiser Permanente |
Phone | 626-720-7463 |
RE-CTCAT@kp.org |
- FeCitrate
- 11035