Secondary HyperparathyroidismPhase 4NCT00073710
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
A Phase 4 study testing Zemplar, 42 Ca carbonate absorption via single tracer method and Calcijex in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Abbott at 1 site in United States.
Trial summary
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- What is being tested?
- Zemplar, 42 Ca carbonate absorption via single tracer method and Calcijex
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to not given
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
- Being tested
- Zemplar, 42 Ca carbonate absorption via single tracer method, Calcijex
- Keywords
- secondary hyperparathyroidism
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZemplarDrug
42 Ca carbonate absorption via single tracer methodProcedure or surgery
CalcijexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2003 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Lund, M.D., Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073710
- Sponsor's protocol ID
- M01-375
- Status last verified
- Jul 2006
- First submitted
- 3 Dec 2003
- Last updated
- 2 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single-Center, Active-Controlled Cross-Over Pilot Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium
- ClinicalTrials.gov ID
- NCT00073710
- Acronym / sponsor ID
- M01-375
- Keywords
- secondary hyperparathyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- First posted
- 4 Dec 2003 (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.
A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Zemplar | Drug | – |
| 42 Ca carbonate absorption via single tracer method | Procedure or surgery | – |
| Calcijex | Drug | – |
Primary outcome
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.
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 2 Aug 2006.
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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.
Richard Lund, M.D. principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zemplar, 42 Ca carbonate absorption via single tracer method and Calcijex in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Abbott 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 12 inclusion and 6 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 2 Aug 2006. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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.. 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 2 Aug 2006; AzTrials last refreshed its copy on 7 Nov 2026.