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Kidney drug trial for infants and toddlers halted early

NCT ID NCT04064827

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a liquid medicine called paricalcitol in children aged 0 to 9 years with severe kidney failure who are on dialysis. The goal was to see if it safely lowers high parathyroid hormone levels, a common complication. The trial was stopped early after enrolling only 2 participants, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

2 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 9 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure hyperparathyroidism secondary hyperparathyroidism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease (CKD) Secondary hyperparathyroidism (SHPT)

Contacts and locations

Locations

  • Arkansas Children's Hospital /ID# 225417

    Little Rock, Arkansas, 72202, United States

  • Atrium Health Wake Forest Baptist Medical Center /ID# 266045

    Winston-Salem, North Carolina, 27157, United States

  • Augusta University Medical Center /ID# 252149

    Augusta, Georgia, 30912-0004, United States

  • Boston Children's Hospital /ID# 162863

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia - Main /ID# 213802

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Childrens National Medical Center /ID# 225991

    Washington D.C., District of Columbia, 20010-2916, United States

  • Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057

    Charlotte, North Carolina, 28203-5866, United States

  • Emory University /ID# 140665

    Atlanta, Georgia, 30322-1014, United States

  • Holtz Childrens Hospital, University of Miami /ID# 225636

    Miami, Florida, 33136-1005, United States

  • Nicklaus Children's Hospital /ID# 210517

    Miami, Florida, 33155-3009, United States

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663

    San Juan, 00935, Puerto Rico

  • Seattle Children's Hospital /ID# 162861

    Seattle, Washington, 98105, United States

  • Stanford University School of Medicine - Redwood City /ID# 252150

    Redwood City, California, 94063, United States

  • University of Texas Southwestern Medical Center /ID# 210495

    Dallas, Texas, 75390-7208, United States

  • University of Utah /ID# 140669

    Salt Lake City, Utah, 84112-5500, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.