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Clinical Trial Details

Trial ID: L1171
Source ID: NCT04064827
Associated Drug: Paricalcitol
Title: 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)
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease (CKD)|Secondary Hyperparathyroidism (SHPT)
Interventions: DRUG: Paricalcitol
Outcome Measures: Primary: Percentage of Participants Who Achieve Positive Response During Dosing Period 1, Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L)., Up to Week 12|Incidence of Hypercalcemia During Dosing Period 1, Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit., Up to Week 12 | Secondary: Percentage of Participants Who Achieve a Positive Response During Dosing Period 2, Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L)., Week 12 through Week 24|Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined, Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L)., Up to Week 24|Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1, Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated., Up to Week 12|Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2, Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated., Week 12 through Week 24|Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined, Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated., Up to Week 24|Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Period 1, Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated., Up to Week 12|Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Period 2, Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated., Week 12 through Week 24|Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Periods 1 and 2 Combined, Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated., Up to Week 24|Incidence of Hypercalcemia During Dosing Period 2, Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit., Week 12 through Week 24|Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined, Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit., Up to Week 24
Sponsor/Collaborators: Sponsor: AbbVie
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-16
Completion Date: 2026-10
Results First Posted:
Last Update Posted: 2025-03-12
Locations: Arkansas Children's Hospital /ID# 225417, Little Rock, Arkansas, 72202, United States|Stanford University /ID# 252150, Redwood City, California, 94063, United States|Children's National Medical Center /ID# 225991, Washington, District of Columbia, 20010-2916, 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|Emory University /ID# 140665, Atlanta, Georgia, 30322-1014, United States|Boston Children's Hospital /ID# 162863, Boston, Massachusetts, 02115, United States|Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057, Charlotte, North Carolina, 28203-5866, United States|Wake Forest University Health Services /ID# 266045, Winston-Salem, North Carolina, 27157-0001, United States|Children's Hospital of Philadelphia - Main /ID# 213802, Philadelphia, Pennsylvania, 19104-4319, 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|Seattle Children's Hospital /ID# 162861, Seattle, Washington, 98105, United States|School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663, San Juan, 00935, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT04064827