Evaluating paricalcitol for treating secondary hyperparathyroidism in children with severe kidney disease
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
This study is testing if a new oral medication called paricalcitol can help young children with severe kidney disease and high parathyroid hormone levels feel better and improve their health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 0 Years to 9 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 15 sites (Little Rock, Arkansas and 14 other locations) |
| Trial ID | NCT04064827 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, efficacy, and pharmacokinetics of paricalcitol oral solution in pediatric patients aged 0 to 9 years who have secondary hyperparathyroidism associated with stage 5 chronic kidney disease. Participants will be receiving either peritoneal dialysis or hemodialysis and will undergo a 24-week treatment period divided into two 12-week dosing phases. The study will monitor the effects of paricalcitol on their condition and overall health.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 9 years diagnosed with stage 5 chronic kidney disease and secondary hyperparathyroidism who are currently on dialysis.
Not a fit: Patients who are scheduled for a kidney transplant within three months or who have already received a kidney transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of secondary hyperparathyroidism in pediatric patients with severe chronic kidney disease.
How similar studies have performed: While there have been studies on paricalcitol in adults, this specific approach in pediatric patients with stage 5 CKD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Little Rock, Arkansas and 14 other locations
- Arkansas Children's Hospital /ID# 225417 — Little Rock, Arkansas, United States (Completed)
- Stanford University /ID# 252150 — Redwood City, California, United States (Recruiting)
- Children's National Medical Center /ID# 225991 — Washington, District of Columbia, United States (Recruiting)
- Holtz Childrens Hospital, University of Miami /ID# 225636 — Miami, Florida, United States (Recruiting)
- Nicklaus Children's Hospital /ID# 210517 — Miami, Florida, United States (Completed)
- Emory University /ID# 140665 — Atlanta, Georgia, United States (Completed)
- Augusta University Medical Center /ID# 252149 — Augusta, Georgia, United States (Recruiting)
- Boston Children's Hospital /ID# 162863 — Boston, Massachusetts, United States (Recruiting)
- Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057 — Charlotte, North Carolina, United States (Completed)
- Wake Forest University Health Services /ID# 266045 — Winston-Salem, North Carolina, United States (Recruiting)
- Children's Hospital of Philadelphia - Main /ID# 213802 — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center /ID# 210495 — Dallas, Texas, United States (Recruiting)
- University of Utah /ID# 140669 — Salt Lake City, Utah, United States (Recruiting)
- Seattle Children's Hospital /ID# 162861 — Seattle, Washington, United States (Completed)
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663 — San Juan, Puerto Rico (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.