Secondary HyperparathyroidismPhase 4NCT00537979

Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis

A Phase 4 study testing Paricalcitol injection and Paricalcitol capsules in people with Secondary Hyperparathyroidism and Dialysis, run by Abbott at 12 sites in Mexico.

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

Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Secondary Hyperparathyroidism, Dialysis
What is being tested?: Paricalcitol injection and Paricalcitol capsules
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 12 sitesMexico
Study dates: Sep 2007to Jul 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
Patients providing their signed informed consent to participate in the trial

Who cannot join

Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum
Patients that in the opinion of the investigator, for any reason, are not good candidates for therapy with Synthetic Analogues of Vitamin D

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Mexico12 sites

Site Ref # / Investigator 19391
Jojutla Morelos, CP 62900
Site Ref # / Investigator 19392
Mexico City, CP 01030
Site Ref # / Investigator 19397
Mexico City, CP 02080
Site Ref # / Investigator 19396
Mexico City, CP 03650
Site Ref # / Investigator 19389
Mexico City, CP 03900
Site Ref # / Investigator 19390
Mexico City, CP 14000
Site Ref # / Investigator 19393
Mexico City, CP 14080
Site Ref # / Investigator 19394
Mexico City, CP 14140
Site Ref # / Investigator 19395
Mexico City, CP 16070
Site Ref # / Investigator 19399
Puebla City, CP 72400
Site Ref # / Investigator 19398
Zapopan, CP 45116
Site Ref # / Investigator 19388
Zapopan, CP 45150

Other trials in Mexico

About this study

Official title: Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis

Conditions: Secondary Hyperparathyroidism, Dialysis
Being tested: Paricalcitol injection, Paricalcitol capsules
Keywords: Dialysis, Hyperparathyroidism, Zemplar
Medical subject headings: Hyperparathyroidism, Secondary, Hyperparathyroidism

What participants receive

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

Paricalcitol injectionDrug
Also called ABT-358, paricalcitol, Zemplar
Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly
Paricalcitol capsulesDrug
Also called ABT-358, paricalcitol, Zemplar
Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly

Study groups in NCT00537979
Study group	Role	What they receive
Paricalcitol injection	Active comparator	ABT-358 Zemplar Receives: Drug: Paricalcitol injection
Paricalcitol capsules	Active comparator	ABT-358 Zemplar Receives: Drug: Paricalcitol capsules

What is being measured

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

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.
Measured: 24 weeks

Secondary outcomes (5)

Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75.
Measured: 24 Weeks
Proportion of Subjects Who Achieve an iPTH <300 pg/mL
Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL.
Measured: 24 weeks
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level
Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%.
Measured: 24 weeks
Duration of Response to Treatment
Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit.
Measured: 24 weeks
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules.
Measured: Baseline and 24 weeks

Timeline

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

Sep 2007Jul 2010

First posted2 Oct 2007 (estimated)
Study startSep 2007
Primary completionJul 2010
Study completionJul 2010

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 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00537979
Sponsor's protocol ID: W10-129
Status last verified: Sep 2011
First submitted: 28 Sep 2007
Last updated: 25 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
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
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Non-randomized, Multicenter Study to Assess the Efficacy and Safety of Oral or Intravenous Paricalcitol Administered Over 6 Months to Patients With Secondary Hyperparathyroidism on Dialysis
ClinicalTrials.gov ID: NCT00537979
Acronym / sponsor ID: W10-129
Conditions: Secondary Hyperparathyroidism, Dialysis
Keywords: Dialysis, Hyperparathyroidism, Zemplar
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 2 Oct 2007 (estimated)
Results: Posted 25 Oct 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paricalcitol injection	Active comparator	Drug: Paricalcitol injectionABT-358 Zemplar
Paricalcitol capsules	Active comparator	Drug: Paricalcitol capsulesABT-358 Zemplar

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients >=18 years with secondary hyperparathyroidism (iPTH >= 300 pg/mL)
Patients in a chronic hemodialysis or peritoneal dialysis program previously treated with vitamin D metabolites or without previous treatment
Patients in which treatment with paricalcitol injection or oral is clinically indicated according to the criteria of the participating investigator
Patients providing their signed informed consent to participate in the trial

Key exclusion criteria (6 listed)

Patients with severe hyperparathyroidism (iPTH > 3,000 pg/ml)
Patients with hypercalcaemia (calcium >=11.0 mg/dl, adjusted according to Albumin level), hyperphosphataemia (phosphorus >= 6.5 mg/dl) or patients with calcium x phosphorus >= 70
Known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients
Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies
Patients who cannot tolerate or take phosphorus binders that do not contain Calcium and/or Aluminum

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
Paricalcitol injectionAlso: ABT-358, paricalcitol, ZemplarMost recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly	Drug	Paricalcitol injection
Paricalcitol capsulesAlso: ABT-358, paricalcitol, ZemplarMost recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly	Drug	Paricalcitol capsules

Primary outcome

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level
Time frame: 24 weeks
Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level.

5 secondary outcomes

Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75)
Time frame: 24 Weeks
Proportion of Subjects Who Achieve an iPTH <300 pg/mL
Time frame: 24 weeks
Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level
Time frame: 24 weeks
Duration of Response to Treatment
Time frame: 24 weeks
Health-related Quality of Life With Paricalcitol Injection or Oral Treatment
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 25 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paricalcitol Injection	38	32
Paricalcitol Capsules	109	89

Primary outcome: Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level

Time frame: 24 weeks. Number. Unit: participants

Measure	Paricalcitol Injection n = 38	Paricalcitol Capsules n = 109
Value	17	57

Population analysed: The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first dose of study drug through 30 days after the last dose of study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol Injection	8 of 38 (21.1%)	25 of 38 (65.8%)	Not reported
Paricalcitol Capsules	9 of 109 (8.3%)	84 of 109 (77.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
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
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

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.

Jose-Luis Cañadas, MD study director

Abbott

12 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 Paricalcitol injection and Paricalcitol capsules in people with Secondary Hyperparathyroidism and Dialysis, run by Abbott at 12 sites in Mexico.

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 4 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 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Mexico. 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 25 Oct 2011). 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?

Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level (time frame: 24 weeks). 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 NCT00537979.

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 25 Oct 2011.