Secondary Hyperparathyroidism
Conditions
Brief summary
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.
Interventions
DRUGSevelamer Carbonate
Daily renvela (800 mg tid with meals) x 12 weeks
OTHERPlacebo
1 inert tablet tid x 12 weeks
Sponsors
Loma Linda University
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2).
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FGF-23 Level | 12 weeks | Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1,25(OH)2vitamin D Value | 12 week | Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks. |
| Serum Phosphate Concentration | 12 weeks | Change in serum phosphate at 12 weeks from baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renvela Daily renvela with meals for 12 weeks
Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks | 9 |
| Placebo Placebo: 1 inert tablet tid x 12 weeks | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Placebo | Renvela | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 9 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Continuous | 15.4 years STANDARD_DEVIATION 4.6 | 13.3 years STANDARD_DEVIATION 3.2 | 14.3 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Change in FGF-23 Level
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renvela | Change in FGF-23 Level | 16 percentage change from baseline | Standard Deviation 41 |
| Placebo | Change in FGF-23 Level | 41 percentage change from baseline | Standard Deviation 46 |
Secondary
1,25(OH)2vitamin D Value
Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
Time frame: 12 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renvela | 1,25(OH)2vitamin D Value | 82 percent change from baseline | Standard Deviation 64 |
| Placebo | 1,25(OH)2vitamin D Value | 69 percent change from baseline | Standard Deviation 82 |
Secondary
Serum Phosphate Concentration
Change in serum phosphate at 12 weeks from baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renvela | Serum Phosphate Concentration | -4 percent change from baseline | Standard Deviation 46 |
| Placebo | Serum Phosphate Concentration | -8 percent change from baseline | Standard Deviation 49 |