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)

Last updated: May 5, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Kidney Failure (Pediatric)

Neoplasm Metastasis

Hyperparathyroidism

Treatment

Paricalcitol

Clinical Study ID

NCT04064827
M11-617
  • Ages < 9
  • All Genders

Study 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). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is currently diagnosed with and/or being treated for secondaryhyperparathyroidism (SHPT).

  • Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receivingperitoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initialScreening.

  • For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naiveparticipants), the participant must meet the appropriate laboratory criteria basedupon the participant's age as described in the protocol.

  • For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naiveparticipants who have completed the Washout Period), the participant must meet theappropriate laboratory criteria based upon the participant's age as described in theprotocol.

Exclusion

Exclusion Criteria:

  • Participant is scheduled to receive a living donor kidney transplant within 3 monthsof 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 adose equivalent to more than > 0.16 mg/kg/day or 5 mg prednisone/day, whichever islower), 4 weeks prior to Dosing.

  • Participant is receiving calcimimetics at the time of Screening or is expected toinitiate calcimimetics at any time throughout the study.

  • Participant is unable to take oral medications.

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Paricalcitol
Phase: 3
Study Start date:
September 16, 2020
Estimated Completion Date:
October 31, 2026

Connect with a study center

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

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • Arkansas Children's Hospital /ID# 225417

    Little Rock, Arkansas 72202
    United States

    Completed

  • University of California, Los Angeles /ID# 140668

    Los Angeles, California 90095
    United States

    Site Not Available

  • Stanford University /ID# 252150

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Stanford University /ID# 252150

    Stanford, California 94305
    United States

    Site Not Available

  • Colorado Children's Hospital /ID# 162862

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's National Medical Center /ID# 225991

    Washington, District of Columbia 20010-2916
    United States

    Active - Recruiting

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

    Miami, Florida 33136-1005
    United States

    Active - Recruiting

  • Nicklaus Children's Hospital /ID# 210517

    Miami, Florida 33155-3009
    United States

    Completed

  • Emory University /ID# 140665

    Atlanta, Georgia 30322-1014
    United States

    Completed

  • Augusta University Medical Center /ID# 252149

    Augusta, Georgia 30912-0004
    United States

    Active - Recruiting

  • Boston Children's Hospital /ID# 162863

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Childrens Mercy Hosp and Clin /ID# 140672

    Kansas City, Missouri 64108
    United States

    Site Not Available

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

    Charlotte, North Carolina 28203-5866
    United States

    Completed

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

    Charlotte, North Carolina 28203-5866
    United States

    Completed

  • Wake Forest University Health Services /ID# 266045

    Winston-Salem, North Carolina 27157-0001
    United States

    Active - Recruiting

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

    Philadelphia, Pennsylvania 19104-4319
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center /ID# 210495

    Dallas, Texas 75390-7208
    United States

    Active - Recruiting

  • University of Utah /ID# 140669

    Salt Lake City, Utah 84112-5500
    United States

    Active - Recruiting

  • Seattle Children's Hospital /ID# 162861

    Seattle, Washington 98105
    United States

    Completed

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