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)

Chronic Kidney Disease (CKD) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04064827
• Other study ID #: M11-617
• Status: Recruiting
• Phase: Phase 3
• Start date: September 16, 2020
• Est. completion date: October 30, 2026

Study information

• Verified date: January 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: October 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism (SHPT)

Intervention

Drug:
• Paricalcitol
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

Locations

Country	Name	City	State
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663	San Juan
United States	Emory University /ID# 140665	Atlanta	Georgia
United States	Boston Children's Hospital /ID# 162863	Boston	Massachusetts
United States	Levine Children's Specialty Center- Charlotte /ID# 216057	Charlotte	North Carolina
United States	University of Texas Southwestern Medical Center /ID# 210495	Dallas	Texas
United States	Arkansas Children's Hospital /ID# 225417	Little Rock	Arkansas
United States	Holtz Childrens Hospital, University of Miami /ID# 225636	Miami	Florida
United States	Nicklaus Children's Hospital /ID# 210517	Miami	Florida
United States	Children's Hospital of Philadelphia - Main /ID# 213802	Philadelphia	Pennsylvania
United States	Stanford University /ID# 252150	Redwood City	California
United States	University of Utah /ID# 140669	Salt Lake City	Utah
United States	Seattle Children's Hospital /ID# 162861	Seattle	Washington
United States	Children's National Medical Center /ID# 225991	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

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