Chronic Kidney Disease, Stage 5Phase 4NCT00257920

A Study of Zemplar® Injection and Hectorol® Injection on Intestinal Absorption of Calcium in Chronic Kidney Disease

A Phase 4 study testing Zemplar® injection and Hectorol® injection in people with Chronic Kidney Disease, Stage 5 and Secondary Hyperparathyroidism, run by Abbott at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
What is being tested?: Zemplar® injection and Hectorol® injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesUnited States
Study dates: Jun 2006to Jan 2008
Phase: Phase 4
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 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 CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit 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 has an intact PTH value > 200 pg/mL at Screening only (or Re-screening, if applicable).
Subject has a serum calcium level < 10.2 mg/dL at Screening only (or Re-screening, if applicable).
Subject has a serum phosphorus level < 6.5 mg/dL at Screening only (or Re-screening, if applicable).
Subject has a CaxP product <= 65 at Screening only (or Re-screening, if applicable).
Subject 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 (SGOT/AST, SGPT/ALT) levels.
Subject has a hemoglobin level < 9.0 g/dL.
Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose > 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, 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

2 sites in 1 country.

United States2 sites

Study site
Bellevue, Nebraska, 68123
Study site
Omaha, Nebraska, 68131

Other trials in United States

About this study

Official title: A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.

Conditions: Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
Being tested: Zemplar® injection, Hectorol® injection
Keywords: Stage 5 Chronic Kidney Disease (CKD)
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zemplar® injectionDrug
Also called ABT-358, paricalcitol, Zemplar
6 mcg QOD
Hectorol® injectionDrug
Also called Hectorol®
3.6 mcg QOD

Study groups in NCT00257920
Study group	Role	What they receive
A	Active comparator	Not described Receives: Drug: Zemplar® injection
B	Active comparator	Not described Receives: Drug: Hectorol® injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
Measured: 42 Days

Secondary outcomes (1)

Calcium Absorption Fractions Analyzed by Mixed Model
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2
Measured: 42 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jan 2008

First posted24 Nov 2005 (estimated)
Study startJun 2006
Primary completionJan 2008

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 Chronic Kidney Disease, Stage 5Studies 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: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00257920
Sponsor's protocol ID: M04-726
Status last verified: Dec 2009
First submitted: 22 Nov 2005
Last updated: 24 Dec 2009
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Single-Center, Open-Label, Randomized, Active-Controlled, Cross-over Pilot Study to Evaluate the Effects of Two Vitamin D Analogs, Zemplar® Injection and Hectorol® Injection, on Intestinal Absorption of Calcium in CKD Stage 5 Subjects on Hemodialysis
ClinicalTrials.gov ID: NCT00257920
Acronym / sponsor ID: M04-726
Conditions: Chronic Kidney Disease, Stage 5, Secondary Hyperparathyroidism
Keywords: Stage 5 Chronic Kidney Disease (CKD)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Jan 2008 (actual)
First posted: 24 Nov 2005 (estimated)
Results: Posted 20 May 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effects of Zemplar® Injection and Hectorol® Injection on intestinal calcium absorption in Chronic Kidney Disease Stage 5 subjects on hemodialysis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Active comparator	Drug: Zemplar® injection
B	Active comparator	Drug: Hectorol® injection

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 CKD Stage 5, and must be on maintenance (chronic) hemodialysis (HD) three times a week for at least 2 months prior to the Screening Visit 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 has an intact PTH value > 200 pg/mL at Screening only (or Re-screening, if applicable).

Key exclusion criteria (7 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 (SGOT/AST, SGPT/ALT) levels.
Subject has a hemoglobin level < 9.0 g/dL.
Subject is taking maintenance calcitonin, Sensipar® (cinacalcet), glucocorticoids in an equivalent dose > 5 mg prednisone daily, or other drugs that may affect calcium or bone metabolism within 2 weeks prior to screening, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.

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® injectionAlso: ABT-358, paricalcitol, Zemplar6 mcg QOD	Drug	A
Hectorol® injectionAlso: Hectorol®3.6 mcg QOD	Drug	B

Primary outcome

Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)
Time frame: 42 Days
Calcium Absorption Fraction obtained at the end of Period 1 \& Period 2

1 secondary outcome

Calcium Absorption Fractions Analyzed by Mixed Model
Time frame: 42 Days

Results and safety

Results posted to the registry on 20 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zemplar First	21	21
Hectorol First	20	20

Primary outcome: Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA)

Time frame: 42 Days. Least squares mean (Standard Error). Unit: Fractions

Measure	Zemplar n = 33	Hectorol n = 33
Value	0.103 (0.007)	0.108 (0.007)

Zemplar vs Hectorol: Mean Difference (Final Values): -0.005 (95% CI -0.024 to 0.014), p = 0.573, ANOVA

Population analysed: Per-Protocol Population - all subjects who completed both Period 1 and 2 and did not have major protocol violations.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zemplar	3 of ?	18 of ?	Not reported
Hectorol	3 of ?	15 of ?	Not reported

Limitations and caveats (from the sponsor): The null hypothesis was not tested appropriately as a result of measurable differences in parathyroid hormone (PTH) suppression indicating dose exposure was different. Therefore, differences in calcium absorption could not be determined.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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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.

2 sites 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® injection and Hectorol® injection in people with Chronic Kidney Disease, Stage 5 and Secondary Hyperparathyroidism, run by Abbott at 2 sites 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 7 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 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 20 May 2009). 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?

Calcium Absorption Fractions Analyzed by Analysis of Variance (ANOVA) (time frame: 42 Days). 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 NCT00257920.

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 24 Dec 2009.