Chronic Kidney Disease
Conditions
Keywords
Serum phosphorus levels
Brief summary
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.
Detailed description
Total 40 subjects will be randomized for participation into the study The subjects are Hemo-dialysis Dependent Chronic Kidney Disease (CKD) Stage 5D patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets.
Interventions
DRUGCalcium acetate oral solution (COS)
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
DRUGSevelamer carbonate
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
Sponsors
Fresenius Medical Care North America
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects ≥18 years of age able to give written informed consent to the study * Hemodialysis dependent chronic kidney disease stage 5D patients * Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy * Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day
Exclusion criteria
* Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status \>1 * Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion * Known hypersensitivity reaction to calcium-based phosphate binders * Anticipated renal transplantation during the study * Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphorus Levels | 2 weeks | The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject |
Countries
United States
Participant flow
Pre-assignment details
A total of 44 subjects signed the informed consent form (ICF), 5 subjects were not eligible, and 1 eligible subject withdrew the ICF prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Sequence I: COS Then Sevelamer Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks | 20 |
| Sequence II: Sevelamer Then COS Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks | 18 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Sequence II: Sevelamer Then COS | Sequence I: COS Then Sevelamer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 20.2 | 60 years STANDARD_DEVIATION 16.3 | 59 years STANDARD_DEVIATION 18 |
| Region of Enrollment United States | 18 participants | 20 participants | 38 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 38 | 6 / 38 |
| serious Total, serious adverse events | 2 / 38 | 1 / 38 |
Outcome results
Primary
Serum Phosphorus Levels
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Time frame: 2 weeks
Population: Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium Acetate Oral Solution | Serum Phosphorus Levels | 4.6 mg/dL | Standard Deviation 1.2 |
| Sevelamer Carbonate | Serum Phosphorus Levels | 4.6 mg/dL | Standard Deviation 0.93 |