End-Stage Renal DiseasePhase 3NCT01382212

A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

A Phase 3 study testing paricalcitol in people with End-Stage Renal Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott).

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

Who is it for?: Ages 10 to 16 years
Conditions the study is for: End-Stage Renal Disease, Secondary Hyperparathyroidism
What is being tested?: paricalcitol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: No sites listed yet
Study dates: Oct 2011to Apr 2015
Phase: Phase 3
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 10 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:
A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
A phosphorus value ≤ 6.5 mg/dL
An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

Who cannot join

Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
Subject has had a parathyroidectomy within 12 weeks prior to Screening
Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
Subject is receiving cinacalcet at the time of Screening

About this study

Official title: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.

Conditions: End-Stage Renal Disease, Secondary Hyperparathyroidism
Being tested: paricalcitol
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Medical subject headings: Kidney Failure, Chronic, Hyperparathyroidism, Secondary

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
Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.

Study groups in NCT01382212
Study group	Role	What they receive
Paricalcitol	Experimental	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. Receives: Drug: paricalcitol

What is being measured

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

Percentage of Subjects With Hypercalcemia
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).
Measured: Day 1 to Week 12

Secondary outcomes (20)

Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
Measured: Baseline (last measurement collected prior to the first dose) to Week 12
Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
Measured: Baseline (last measurement collected prior to the first dose) to Week 12
Hemoglobin: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hematocrit: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Red Blood Cells: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Alkaline Phosphatase: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Total Protein and Albumin: Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Osteocalcin: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Number of Subjects With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Measured: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.
Measured: Baseline (Day 1) to Final Visit (up to Week 12)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
Blood pressure was measured after the subject had been sitting for at least 3 minutes.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Heart Rate: Mean Change From Baseline to Final Visit
Heart rate was measured after the subject had been sitting for at least 3 minutes.
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Oral Body Temperature: Mean Change From Baseline to Final Visit
Measured: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Number of Subjects With Potentially Clinically Significant Physical Examination Findings
Measured: Baseline (Day 1) and Final Visit (up to Week 12)

Timeline

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

Oct 2011Apr 2015

First posted27 Jun 2011 (estimated)
Study startOct 2011
Primary completionApr 2015
Study completionApr 2015

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal DiseaseStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01382212
Sponsor's protocol ID: M11-612
Other IDs: 2013-002610-13
Status last verified: Nov 2016
First submitted: 24 Jun 2011
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.
PubMed 28332096

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?

Official record

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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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All End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
ClinicalTrials.gov ID: NCT01382212
Acronym / sponsor ID: M11-612
Conditions: End-Stage Renal Disease, Secondary Hyperparathyroidism
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 27 Jun 2011 (estimated)
Results: Posted 21 Nov 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paricalcitol	Experimental	Drug: paricalcitolOpen-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Who may qualify

Ages: 10 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism
For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:

Key exclusion criteria (6 listed)

Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
Subject has had a parathyroidectomy within 12 weeks prior to Screening
Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing

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, ZemplarParicalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.	Drug	Paricalcitol

Primary outcome

Percentage of Subjects With Hypercalcemia
Time frame: Day 1 to Week 12
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).

20 secondary outcomes

Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
Time frame: Baseline (last measurement collected prior to the first dose) to Week 12
Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
Time frame: Baseline (last measurement collected prior to the first dose) to Week 12
Hemoglobin: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hematocrit: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Red Blood Cells: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Alkaline Phosphatase: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Total Protein and Albumin: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Osteocalcin: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Number of Subjects With Adverse Events
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Baseline (Day 1) to Final Visit (up to Week 12)
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Heart Rate: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Oral Body Temperature: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Number of Subjects With Potentially Clinically Significant Physical Examination Findings
Time frame: Baseline (Day 1) and Final Visit (up to Week 12)

Results and safety

Results posted to the registry on 21 Nov 2016, 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	13	11

Primary outcome: Percentage of Subjects With Hypercalcemia

Time frame: Day 1 to Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Paricalcitol n = 13
Value	15.3 (1.9 to 45.4)

Population analysed: All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol

20 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol	2 of 13 (15.4%)	10 of 13 (76.9%)	Not reported

Limitations and caveats (from the sponsor): The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28332096Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.
Prescribing InformationLink provided by the sponsor.

Related trials for End-Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
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RecruitingObservational study
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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.

Ann Eldred, MD study director

AbbVie

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paricalcitol in people with End-Stage Renal Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott).

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 6 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 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Nov 2016). 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 Subjects With Hypercalcemia (time frame: Day 1 to Week 12). 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 NCT01382212, which also lists 1 linked publication.

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 Jul 2018.