Chronic Kidney Disease (CKD)Phase 3NCT04064827

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

A Phase 3 study testing Paricalcitol in people with Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT), run by AbbVie at 15 sites in 2 countries.

Terminated

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

Official record

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Trial summary

The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). Read more about this study

Who is it for?: Ages 0 to 9 years
Conditions the study is for: Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
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: 2 participants
Where: 15 sitesin 2 countries
Study dates: 16 Sep 2020to 9 Jun 2025
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 0 to 9 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.

Who cannot join

Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
Participant has had a parathyroidectomy within 12 weeks prior to Screening.
Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
Participant is unable to take oral medications.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

United States14 sites

Emory University /ID# 140665
Atlanta, Georgia, 30322-1014
Augusta University Medical Center /ID# 252149
Augusta, Georgia, 30912-0004
Boston Children's Hospital /ID# 162863
Boston, Massachusetts, 02115
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte, North Carolina, 28203-5866
University of Texas Southwestern Medical Center /ID# 210495
Dallas, Texas, 75390-7208
Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas, 72202
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami, Florida, 33136-1005
Nicklaus Children's Hospital /ID# 210517
Miami, Florida, 33155-3009
Children's Hospital of Philadelphia - Main /ID# 213802
Philadelphia, Pennsylvania, 19104-4319
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City, California, 94063
University of Utah /ID# 140669
Salt Lake City, Utah, 84112-5500
Seattle Children's Hospital /ID# 162861
Seattle, Washington, 98105
Childrens National Medical Center /ID# 225991
Washington D.C., District of Columbia, 20010-2916
Atrium Health Wake Forest Baptist Medical Center /ID# 266045
Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico1 site

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Conditions: Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Being tested: Paricalcitol
Keywords: Chronic Kidney Disease, Paricalcitol, Hyperparathyroidism, Pediatric Subjects, Peritoneal Dialysis (PD), Hemodialysis (HD), Intact parathyroid hormone (iPTH)
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Hyperparathyroidism

What participants receive

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

ParicalcitolDrug
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

Study groups in NCT04064827
Study group	Role	What they receive
Participants Receiving Paricalcitol	Experimental	Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Receives: Drug: Paricalcitol

What is being measured

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

Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Positive response is defined as having two consecutive >= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole[pmol]/L).
Measured: Up to Week 12
Incidence of Hypercalcemia During Dosing Period 1
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Measured: Up to Week 12

Secondary outcomes (10)

Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
Positive response is defined as having two consecutive >= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole[pmol]/L).
Measured: Week 12 through Week 24
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
Positive response is defined as having two consecutive >= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole[pmol]/L).
Measured: Up to Week 24
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Measured: Up to Week 12
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Measured: Week 12 through Week 24
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Measured: Up to Week 24
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Measured: Up to Week 12
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Measured: Week 12 through Week 24
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Measured: Up to Week 24
Incidence of Hypercalcemia During Dosing Period 2
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Measured: Week 12 through Week 24
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Measured: Up to Week 24

Timeline

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

16 Sep 20209 Jun 2025

First posted22 Aug 2019
Study start16 Sep 2020
Primary completion9 Jun 2025
Study completion9 Jun 2025

Why it stopped: Company Decision

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 (CKD)Studies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
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: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04064827
Sponsor's protocol ID: M11-617
Status last verified: Dec 2025
First submitted: 20 Aug 2019
Last updated: 15 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
ClinicalTrials.gov ID: NCT04064827
Acronym / sponsor ID: M11-617
Conditions: Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Keywords: Chronic Kidney Disease, Paricalcitol, Hyperparathyroidism, Pediatric Subjects, Peritoneal Dialysis (PD), Hemodialysis (HD), Intact parathyroid hormone (iPTH)
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Company Decision
Enrolment: 2 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 16 Sep 2020 (actual)
Primary completion: 9 Jun 2025 (actual)
Study completion: 9 Jun 2025 (actual)
First posted: 22 Aug 2019 (actual)
Results: Posted 15 Jun 2026

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
Participants Receiving Paricalcitol	Experimental	Drug: ParicalcitolParticipants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks

Who may qualify

Ages: 0 to 9 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.

Key exclusion criteria (6 listed)

Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
Participant has had a parathyroidectomy within 12 weeks prior to Screening.
Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.

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
ParicalcitolParicalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser	Drug	Participants Receiving Paricalcitol

Primary outcome

Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Time frame: Up to Week 12
Positive response is defined as having two consecutive >= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole[pmol]/L).
Incidence of Hypercalcemia During Dosing Period 1
Time frame: Up to Week 12
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

10 secondary outcomes

Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
Time frame: Week 12 through Week 24
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
Time frame: Up to Week 24
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
Time frame: Up to Week 12
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
Time frame: Week 12 through Week 24
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
Time frame: Up to Week 24
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1
Time frame: Up to Week 12
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2
Time frame: Week 12 through Week 24
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined
Time frame: Up to Week 24
Incidence of Hypercalcemia During Dosing Period 2
Time frame: Week 12 through Week 24
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 15 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants Receiving Paricalcitol	2	1

Primary outcome: Percentage of Participants Who Achieve Positive Response During Dosing Period 1

Time frame: Up to Week 12. Number. Unit: percentage of participants

Measure	Participants Receiving Paricalcitol n = 2
Value	100

Primary outcome: Incidence of Hypercalcemia During Dosing Period 1

Time frame: Up to Week 12. Count of participants. Unit: Participants

Measure	Participants Receiving Paricalcitol n = 2
Value	0

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Receiving Paricalcitol	2 of 2 (100%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

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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.

ABBVIE INC. study director

AbbVie

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paricalcitol in people with Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT), run by AbbVie at 15 sites in 2 countries.

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: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Puerto Rico. 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 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 15 Jun 2026). 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 Who Achieve Positive Response During Dosing Period 1 (time frame: Up to Week 12). The study lists 2 primary outcomes in all. 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 NCT04064827.

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 15 Jun 2026.