Leállítva3. fázis
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 legfontosabb adatok
- Ki végzi
- AbbVie
- Hol
- Atlanta, Augusta, Boston, Charlotte, Dallas, Little Rock, Miami, Philadelphia, Redwood City, Salt Lake City, Seattle, Washington D.C. és Winston-Salem (Egyesült Államok)Mind a 14 helyszín megnézéseMég 1 másik országban, 1 helyszínen
- Azonosító
- Állapot
- Leállítva
- Fázis
- 3. fázis
- Résztvevők
- 2 fő vett részt
- Kezdés
- 2020. szept. 16.
- Befejezés
- 2025. jún. 9.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Paricalcitol
- A regiszteradat frissítve
- 2026. június 15.
- Miért állt le
- Company Decision
Ki vehet részt
- Életkor
- 0 év – 9 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 10 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient
- 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
- Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 1 helyszínen
- Emory University /ID# 140665Atlanta, Egyesült ÁllamokNo longer taking part
- Augusta University Medical Center /ID# 252149Augusta, Egyesült ÁllamokNo longer taking part
- Boston Children's Hospital /ID# 162863Boston, Egyesült ÁllamokNo longer taking part
- Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057Charlotte, Egyesült ÁllamokNo longer taking part
- University of Texas Southwestern Medical Center /ID# 210495Dallas, Egyesült ÁllamokNo longer taking part
- Arkansas Children's Hospital /ID# 225417Little Rock, Egyesült ÁllamokNo longer taking part
- Holtz Childrens Hospital, University of Miami /ID# 225636Miami, Egyesült ÁllamokNo longer taking part
- Nicklaus Children's Hospital /ID# 210517Miami, Egyesült ÁllamokNo longer taking part
- Children's Hospital of Philadelphia - Main /ID# 213802Philadelphia, Egyesült ÁllamokNo longer taking part
- Stanford University School of Medicine - Redwood City /ID# 252150Redwood City, Egyesült ÁllamokNo longer taking part
- University of Utah /ID# 140669Salt Lake City, Egyesült ÁllamokNo longer taking part
- Seattle Children's Hospital /ID# 162861Seattle, Egyesült ÁllamokNo longer taking part
- Childrens National Medical Center /ID# 225991Washington D.C., Egyesült ÁllamokNo longer taking part
- Atrium Health Wake Forest Baptist Medical Center /ID# 266045Winston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A vizsgálat csoportja
- Participants Receiving ParicalcitolA vizsgált kezelés
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Kezelés: Paricalcitol
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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
- A regiszteradat frissítve
- 2026. június 15.