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)

• ClinicalTrials.gov Identifier: NCT04064827
• Recruitment Status: Recruiting
• First Posted: August 22, 2019
• Last Update Posted: March 21, 2023
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Study Description

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	Intervention/treatment	Phase
Chronic Kidney Disease (CKD); Secondary Hyperparathyroidism (SHPT)	Drug: Paricalcitol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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: September 16, 2020
• Estimated Primary Completion Date: June 30, 2026
• Estimated Study Completion Date: October 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Participants Receiving Paricalcitol; Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks	Drug: Paricalcitol; Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Who Achieve Positive Response During Dosing Period 1 [ Time Frame: Up to Week 12 ]
   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).
2. Incidence of Hypercalcemia During Dosing Period 1 [ Time Frame: Up to Week 12 ]
   Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Secondary Outcome Measures :

1. Percentage of Participants Who Achieve a Positive Response During Dosing Period 2 [ Time Frame: Week 12 through Week 24 ]
   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).
2. Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined [ Time Frame: Up to Week 24 ]
   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).
3. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1 [ Time Frame: Up to Week 12 ]
   Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
4. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2 [ Time Frame: Week 12 through Week 24 ]
   Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
5. Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined [ Time Frame: Up to Week 24 ]
   Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
6. 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 [ Time Frame: Up to Week 12 ]
   Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
7. 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 [ Time Frame: Week 12 through Week 24 ]
   Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
8. 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 [ Time Frame: Up to Week 24 ]
   Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
9. Incidence of Hypercalcemia During Dosing Period 2 [ Time Frame: Week 12 through Week 24 ]
   Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
10. Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined [ Time Frame: Up to Week 24 ]
    Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Eligibility Criteria

• Ages Eligible for Study: 0 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 expected or scheduled to receive a kidney transplant within 6 months of Screening or is a kidney transplant recipient.
• Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 6 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.

Contacts and Locations

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

Locations

United States, Arkansas

Arkansas Children's Hospital /ID# 225417; Completed

Little Rock, Arkansas, United States, 72202

United States, California

Stanford University /ID# 252150; Not yet recruiting

Stanford, California, United States, 94305

United States, District of Columbia

Children's National Medical Center /ID# 225991; Recruiting

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

United States, Florida

Holtz Childrens Hospital, University of Miami /ID# 225636; Recruiting

Miami, Florida, United States, 33136-1005

Nicklaus Children's Hospital /ID# 210517; Completed

Miami, Florida, United States, 33155-3009

United States, Georgia

Emory University /ID# 140665; Recruiting

Atlanta, Georgia, United States, 30322-1014

United States, Massachusetts

Boston Children's Hospital /ID# 162863; Recruiting

Boston, Massachusetts, United States, 02115

United States, North Carolina

Levine Children's Specialty Center- Charlotte /ID# 216057; Recruiting

Charlotte, North Carolina, United States, 28203-5866

Contact: Site Coordinator 844-663-3742

United States, Pennsylvania

Children's Hospital of Philadelphia - Main /ID# 213802; Not yet recruiting

Philadelphia, Pennsylvania, United States, 19104-4319

United States, Texas

University of Texas Southwestern Medical Center /ID# 210495; Recruiting

Dallas, Texas, United States, 75390-7208

United States, Utah

University of Utah /ID# 140669; Recruiting

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

United States, Washington

Seattle Children's Hospital /ID# 162861; Recruiting

Seattle, Washington, United States, 98105

Puerto Rico

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

San Juan, Puerto Rico, 00935

Contact: Site Coordinator 844-663-3742

Sponsors and Collaborators

AbbVie

Investigators

• Study Director: ABBVIE INC.; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT04064827
• Other Study ID Numbers: M11-617
• First Posted: August 22, 2019
• Last Update Posted: March 21, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• URL: https://vivli.org/ourmember/abbvie/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by AbbVie:

Chronic Kidney Disease; Paricalcitol; Hyperparathyroidism; Pediatric Subjects; Peritoneal Dialysis (PD); Hemodialysis (HD); Intact parathyroid hormone (iPTH)

Additional relevant MeSH terms:

Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary; Urologic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Renal Insufficiency; Parathyroid Diseases; Endocrine System Diseases