NCT00073710

Brief Summary

A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 3, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2003

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2004

Completed
Last Updated

August 2, 2006

Status Verified

July 1, 2006

First QC Date

December 3, 2003

Last Update Submit

July 31, 2006

Conditions

Secondary HyperparathyroidismChronic Kidney Disease

Keywords

secondary hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • The mean within subject difference in calcium absorption rates between treatment regimens will be analyzed using ANOVA appropriate for a two-period cross-over trial.

Interventions

ZemplarDRUG
42 Ca carbonate absorption via single tracer methodPROCEDURE
CalcijexDRUG

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is ≥ 20 years of age.
  • Subject is diagnosed with ESRD, and must be on maintenance hemodialysis (HD) three times a week for at least 2 months prior to the Screening Phase and expected to remain on HD for the duration of the study.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
  • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
  • Contraceptives (oral or parenteral) for three months prior to study drug administration
  • In a monogamous relationship with a vasectomized partner
  • If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
  • Subject had an intact PTH value \> 200 pg/mL.
  • Serum calcium level \< 10.2 mg/dL at Screening visit.
  • Serum phosphorus level \< 6.5 mg/dL at Screening visit.
  • Ca´P product ≤ 65 at Screening visit.
  • Must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure

You may not qualify if:

  • Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
  • Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
  • Liver function defects defined as \> 2 times the upper limit of normal for liver enzyme or \> 1.5 times the upper limit of normal coagulation levels.
  • Subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose \> 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
  • For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D.
  • Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryRenal Insufficiency, Chronic

Interventions

paricalcitolCalcitriol

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Richard Lund, M.D.

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2003

First Posted

December 4, 2003

Study Start

September 1, 2004

Last Updated

August 2, 2006

Record last verified: 2006-07

Locations

US(1)