Secondary HyperparathyroidismNCT01134315

Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

An observational study of Secondary Hyperparathyroidism and End-Stage Renal Disease, run by AbbVie (prior sponsor, Abbott) at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages Up to 16 years
Conditions the study is for: Secondary Hyperparathyroidism, End-Stage Renal Disease
What is being tested?: Paricalcitol and Calcitriol
Type of treatment: Pill or oral medicine
How many people: 61 participants
Where: 18 sitesUnited States
Study dates: Jun 2010to May 2012
Phase: Observational
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 Up to 16 years
All sexes
No healthy volunteers
Child

Study population: This was a multicenter, United States only study of pediatric (0 to 16 years) males and females receiving peritoneal dialysis, treated in a routine clinical setting. Patients were recruited from private nephrology practices or hospitals.

Who may be able to join

Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
Patient has received paricalcitol or calcitriol for a minimum of 10 days.

Who cannot join

Patient is scheduled for a kidney transplant within 3 months.
Patient is expected to stop peritoneal dialysis within 3 months.
Patient is expected to transfer to hemodialysis within 3 months.
Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Site Reference ID/Investigator# 26749
Akron, Ohio, 44308
Site Reference ID/Investigator# 26748
Atlanta, Georgia, 30322
Site Reference ID/Investigator# 39973
Baltimore, Maryland, 21287
Site Reference ID/Investigator# 37082
Birmingham, Alabama, 35255
Site Reference ID/Investigator# 26769
Boston, Massachusetts, 02115
Site Reference ID/Investigator# 28526
Charlottesville, Virginia, 22908
Site Reference ID/Investigator# 26751
Cincinnati, Ohio, 45229
Site Reference ID/Investigator# 26765
Columbus, Ohio, 43205
Site Reference ID/Investigator# 26768
Detroit, Michigan, 48201
Site Reference ID/Investigator# 26762
Gainesville, Florida, 32610
Site Reference ID/Investigator# 26747
Kansas City, Missouri, 64108
Site Reference ID/Investigator# 40382
Madison, Wisconsin, 53792
Site Reference ID/Investigator# 37582
New Orleans, Louisiana, 70118
Site Reference ID/Investigator# 28528
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 28529
Orlando, Florida, 32801
Site Reference ID/Investigator# 26763
Portland, Oregon, 97227
Site Reference ID/Investigator# 26758
Seattle, Washington, 98105
Site Reference ID/Investigator# 26759
Wauwatosa, Wisconsin, 53226

Other trials in United States

About this study

Official title: A Prospective, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules as Determined by Hypercalcemia in Pediatric Patients Ages 0 to 16 With Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) Within Current Clinical Practice

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Read the detailed description

Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.

Conditions: Secondary Hyperparathyroidism, End-Stage Renal Disease
Being tested: Paricalcitol, Calcitriol
Keywords: Evaluating incidence of hypercalcemia in pediatric patients
Medical subject headings: Hyperparathyroidism, Secondary, Kidney Failure, Chronic

What participants receive

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

ParicalcitolDrug
Also called ABT-358, Zemplar
CalcitriolDrug

Study groups in NCT01134315
Study group	Role	What they receive
Paricalcitol		Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician. Receives: Drug: Paricalcitol
Calcitriol		Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician. Receives: Drug: Calcitriol

What is being measured

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

Percentage of Participants With at Least One Incidence of Hypercalcemia
Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.
Measured: Monitored from time of informed consent through end of study + 30 days (total of 745 days).

Secondary outcomes (7)

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.
Measured: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Measured: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

Timeline

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

Jun 2010May 2012

First posted2 Jun 2010 (estimated)
Study startJun 2010
Primary completionMay 2012
Study completionMay 2012

Why it stopped: Terminated after FDA agreement.

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134315
Sponsor's protocol ID: P12-053
Status last verified: May 2013
First submitted: 28 May 2010
Last updated: 13 Aug 2013
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 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules as Determined by Hypercalcemia in Pediatric Patients Ages 0 to 16 With Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) Within Current Clinical Practice
ClinicalTrials.gov ID: NCT01134315
Acronym / sponsor ID: P12-053
Conditions: Secondary Hyperparathyroidism, End-Stage Renal Disease
Keywords: Evaluating incidence of hypercalcemia in pediatric patients
Study type: Observational
Recruitment status: TerminatedReason stopped: Terminated after FDA agreement.
Enrolment: 61 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
Study start: Jun 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 13 Aug 2013

Clinical summary

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Paricalcitol	–	Drug: ParicalcitolPediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
Calcitriol	–	Drug: CalcitriolPediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Who may qualify

Ages: Up to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: This was a multicenter, United States only study of pediatric (0 to 16 years) males and females receiving peritoneal dialysis, treated in a routine clinical setting. Patients were recruited from private nephrology practices or hospitals.

Key inclusion criteria (5 listed)

Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
Patient has received paricalcitol or calcitriol for a minimum of 10 days.

Key exclusion criteria (4 listed)

Patient is scheduled for a kidney transplant within 3 months.
Patient is expected to stop peritoneal dialysis within 3 months.
Patient is expected to transfer to hemodialysis within 3 months.
Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.

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
ParicalcitolAlso: ABT-358, Zemplar	Drug	Paricalcitol
Calcitriol	Drug	Calcitriol

Primary outcome

Percentage of Participants With at Least One Incidence of Hypercalcemia
Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.

7 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])

Results and safety

Results posted to the registry on 13 Aug 2013, 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	21	12
Calcitriol	40	21

Primary outcome: Percentage of Participants With at Least One Incidence of Hypercalcemia

Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).. Number. Unit: percentage of participants

Measure	Paricalcitol n = 19	Calcitriol n = 37
Overall population (n=19, 37)	36.8	54.1
Participants <3 months in study (n=2, 5)	50.0	0
Participants >=3 months in study (n=17, 32)	35.3	62.5

Population analysed: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol	8 of 21 (38.1%)	15 of 21 (71.4%)	Not reported
Calcitriol	26 of 40 (65%)	29 of 40 (72.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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.

Ann Eldred, MD study director

AbbVie

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Hyperparathyroidism and End-Stage Renal Disease, run by AbbVie (prior sponsor, Abbott) at 18 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2013). 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?

Percentage of Participants With at Least One Incidence of Hypercalcemia (time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 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 NCT01134315.

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 13 Aug 2013.