Secondary HyperparathyroidismPhase 2NCT00560300
Regulation of Bone Formation in Renal Osteodystrophy
A Phase 2 study testing 1 alpha D2, 1,25 dihydroxy vitamin D3 and Sevelamer HCl in people with Secondary Hyperparathyroidism and Renal Osteodystrophy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Trial summary
To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Secondary Hyperparathyroidism, Renal Osteodystrophy
- What is being tested?
- 1 alpha D2, 1,25 dihydroxy vitamin D3 and Sevelamer HCl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
- Biochemical evidence of secondary hyperparathyroidism (PTH>400 pg/ml) with bone biopsy evidence of high turnover bone disease
Who cannot join
- History of parathyroidectomy
- Growth hormone
- Prednisone, or other immunosuppressant medication within the past year.
- Recent history of medication non-compliance.
About this study
To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
Read the detailed description
Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.
- Being tested
- 1 alpha D2, 1,25 dihydroxy vitamin D3, Sevelamer HCl, Calcium Carbonate
- Medical subject headings
- Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 alpha D2Drug
Also called Doxercalciferol, Hectoral
Vitamin D sterol
1,25 dihydroxy vitamin D3Drug
Also called Calcitriol, Rocaltrol
Active vitamin D sterol
Sevelamer HClDrug
Also called Renagel
Phosphate binder
Calcium CarbonateDrug
Also called Tums, Titrilac
Phosphate binder
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Doxercalciferol + Calcium Carbonate Receives: Drug: 1 alpha D2; Drug: Calcium Carbonate |
| 2 | Experimental | Doxercalciferol + Sevelamer Receives: Drug: 1 alpha D2; Drug: Sevelamer HCl |
| 3 | Experimental | Calcitriol + Calcium Carbonate Receives: Drug: 1,25 dihydroxy vitamin D3; Drug: Calcium Carbonate |
| 4 | Experimental | Calcitriol + Sevelamer Receives: Drug: 1,25 dihydroxy vitamin D3; Drug: Sevelamer HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Formation Rate
Measured: 8 months
Secondary outcomes (1)
Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startNov 2000
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Isidro B Salusky, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560300
- Sponsor's protocol ID
- DK35423 (completed)
- Status last verified
- Jan 2010
- First submitted
- 13 Nov 2007
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Bone Formation in Renal Osteodystrophy
- ClinicalTrials.gov ID
- NCT00560300
- Acronym / sponsor ID
- DK35423 (completed)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Nov 2000
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
Detailed description
Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 1 alpha D2, Drug: Calcium CarbonateDoxercalciferol + Calcium Carbonate |
| 2 | Experimental | Drug: 1 alpha D2, Drug: Sevelamer HClDoxercalciferol + Sevelamer |
| 3 | Experimental | Drug: 1,25 dihydroxy vitamin D3, Drug: Calcium CarbonateCalcitriol + Calcium Carbonate |
| 4 | Experimental | Drug: 1,25 dihydroxy vitamin D3, Drug: Sevelamer HClCalcitriol + Sevelamer |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
- Biochemical evidence of secondary hyperparathyroidism (PTH>400 pg/ml) with bone biopsy evidence of high turnover bone disease
Key exclusion criteria (4 listed)
- History of parathyroidectomy
- Growth hormone
- Prednisone, or other immunosuppressant medication within the past year.
- Recent history of medication non-compliance.
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 |
|---|---|---|
| 1 alpha D2Also: Doxercalciferol, HectoralVitamin D sterol | Drug | 1, 2 |
| 1,25 dihydroxy vitamin D3Also: Calcitriol, RocaltrolActive vitamin D sterol | Drug | 3, 4 |
| Sevelamer HClAlso: RenagelPhosphate binder | Drug | 2, 4 |
| Calcium CarbonateAlso: Tums, TitrilacPhosphate binder | Drug | 1, 3 |
Primary outcome
Bone Formation Rate
Time frame: 8 months
1 secondary outcome
Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Related trials for Secondary Hyperparathyroidism
RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
Hyperparathyroidism, Secondary, Kidney Failure, Chronic
RecruitingPhase 3
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Secondary Hyperparathyroidism
RecruitingPhase 2
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Evaluation of CTAP101 Extended-release Capsules in Pediatric Participants
CKD Stage 3, CKD Stage 4
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.
Isidro B Salusky, MD principal investigator
University of California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 alpha D2, 1,25 dihydroxy vitamin D3 and Sevelamer HCl in people with Secondary Hyperparathyroidism and Renal Osteodystrophy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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 2 inclusion and 4 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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone Formation Rate (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560300, which also lists 1 linked publication.
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 14 Jan 2010; AzTrials last refreshed its copy on 6 Nov 2026.