Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04064827 | RECRUITING | Chronic Kidney Disease (CKD)

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)
Sponsor:

AbbVie

Brief 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).

Condition or disease

Chronic Kidney Disease (CKD)

Secondary Hyperparathyroidism (SHPT)

Intervention/treatment

Paricalcitol

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2020-09-16
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 0 Years to 9 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 more than \> 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.
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)

Location Details

NCT04064827

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

COMPLETED

United States, Arkansa

Arkansas Children's Hospital /ID# 225417

Little Rock, Arkansa, United States, 72202

RECRUITING

United States, California

Stanford University /ID# 252150

Redwood City, California, United States, 94063

RECRUITING

United States, District of Columbia

Children's National Medical Center /ID# 225991

Washington, District of Columbia, United States, 20010-2916

RECRUITING

United States, Florida

Holtz Childrens Hospital, University of Miami /ID# 225636

Miami, Florida, United States, 33136-1005

COMPLETED

United States, Florida

Nicklaus Children's Hospital /ID# 210517

Miami, Florida, United States, 33155-3009

COMPLETED

United States, Georgia

Emory University /ID# 140665

Atlanta, Georgia, United States, 30322-1014

RECRUITING

United States, Massachusetts

Boston Children's Hospital /ID# 162863

Boston, Massachusetts, United States, 02115

COMPLETED

United States, North Carolina

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

Charlotte, North Carolina, United States, 28203-5866

RECRUITING

United States, North Carolina

Wake Forest University Health Services /ID# 266045

Winston-Salem, North Carolina, United States, 27157-0001

RECRUITING

United States, Pennsylvania

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

Philadelphia, Pennsylvania, United States, 19104-4319

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center /ID# 210495

Dallas, Texas, United States, 75390-7208

RECRUITING

United States, Utah

University of Utah /ID# 140669

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

COMPLETED

United States, Washington

Seattle Children's Hospital /ID# 162861

Seattle, Washington, United States, 98105

RECRUITING

Puerto Rico,

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

San Juan, Puerto Rico, 00935