NCT00560300

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 13, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

November 13, 2007

Last Update Submit

January 12, 2010

Conditions

Secondary HyperparathyroidismRenal Osteodystrophy

Outcome Measures

Primary Outcomes (1)

  • Bone Formation Rate

    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)

    8 months

Study Arms (4)

1

EXPERIMENTAL

Doxercalciferol + Calcium Carbonate

Drug: 1 alpha D2Drug: Calcium Carbonate

2

EXPERIMENTAL

Doxercalciferol + Sevelamer

Drug: 1 alpha D2Drug: Sevelamer HCl

3

EXPERIMENTAL

Calcitriol + Calcium Carbonate

Drug: 1,25 dihydroxy vitamin D3Drug: Calcium Carbonate

4

EXPERIMENTAL

Calcitriol + Sevelamer

Drug: 1,25 dihydroxy vitamin D3Drug: Sevelamer HCl

Interventions

1 alpha D2DRUG

Vitamin D sterol

Also known as: Doxercalciferol, Hectoral
12
1,25 dihydroxy vitamin D3DRUG

Active vitamin D sterol

Also known as: Calcitriol, Rocaltrol
34
Sevelamer HClDRUG

Phosphate binder

Also known as: Renagel
24
Calcium CarbonateDRUG

Phosphate binder

Also known as: Tums, Titrilac
13

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History of parathyroidectomy
  • Growth hormone
  • Prednisone, or other immunosuppressant medication within the past year.
  • Recent history of medication non-compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 40576086DERIVED

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryChronic Kidney Disease-Mineral and Bone Disorder

Interventions

1 alpha-hydroxyergocalciferolCalcitriolSevelamerCalcium Carbonate

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsPolyaminesAminesOrganic ChemicalsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Isidro B Salusky, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 19, 2007

Study Start

November 1, 2000

Study Completion

November 1, 2006

Last Updated

January 14, 2010

Record last verified: 2010-01