Secondary HyperparathyroidismNCT00999037
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
A study testing Sevelamer Carbonate in people with Secondary Hyperparathyroidism, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Sevelamer Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Sevelamer Carbonate, Placebo
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer CarbonateDrug
Also called Renvela
Daily renvela (800 mg tid with meals) x 12 weeks
PlaceboOther
1 inert tablet tid x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Renvela | Experimental | Daily renvela with meals for 12 weeks Receives: Drug: Sevelamer Carbonate |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FGF-23 Level
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
Measured: 12 weeks
Secondary outcomes (2)
1,25(OH)2vitamin D Value
Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
Measured: 12 week
Serum Phosphate Concentration
Change in serum phosphate at 12 weeks from baseline
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Loma Linda University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999037
- Sponsor's protocol ID
- 1K23DK080984-01A1
- Status last verified
- May 2023
- First submitted
- 20 Oct 2009
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00999037
- Acronym / sponsor ID
- 1K23DK080984-01A1
- Conditions
- Secondary Hyperparathyroidism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Loma Linda University
- Study start
- Oct 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renvela | Experimental | Drug: Sevelamer CarbonateDaily renvela with meals for 12 weeks |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevelamer CarbonateAlso: RenvelaDaily renvela (800 mg tid with meals) x 12 weeks | Drug | Renvela |
| Placebo1 inert tablet tid x 12 weeks | Other | placebo |
Primary outcome
Change in FGF-23 Level
Time frame: 12 weeks
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
2 secondary outcomes
1,25(OH)2vitamin D Value
Time frame: 12 week
Serum Phosphate Concentration
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevelamer Carbonate in people with Secondary Hyperparathyroidism, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FGF-23 Level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.