Back to resultsA 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)
Primary Purpose
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paricalcitol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease (CKD) focused on measuring Chronic Kidney Disease, Paricalcitol, Hyperparathyroidism, Pediatric Subjects, Peritoneal Dialysis (PD), Hemodialysis (HD), Intact parathyroid hormone (iPTH)
Eligibility 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.
Sites / Locations
- Arkansas Children's Hospital /ID# 225417
- Children's National Medical Center /ID# 225991Recruiting
- Holtz Childrens Hospital, University of Miami /ID# 225636Recruiting
- Nicklaus Children's Hospital /ID# 210517
- Emory University /ID# 140665
- Boston Children's Hospital /ID# 162863Recruiting
- Levine Children's Specialty Center- Charlotte /ID# 216057
- Children's Hospital of Philadelphia - Main /ID# 213802Recruiting
- University of Texas Southwestern Medical Center /ID# 210495Recruiting
- University of Utah /ID# 140669Recruiting
- Seattle Children's Hospital /ID# 162861Recruiting
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants Receiving Paricalcitol
Arm Description
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04064827
Brief 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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
Keywords
Chronic Kidney Disease, Paricalcitol, Hyperparathyroidism, Pediatric Subjects, Peritoneal Dialysis (PD), Hemodialysis (HD), Intact parathyroid hormone (iPTH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants Receiving Paricalcitol
Arm Type
Experimental
Arm Description
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Intervention Description
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Description
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).
Time Frame
Up to Week 12
Title
Incidence of Hypercalcemia During Dosing Period 1
Description
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
Description
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).
Time Frame
Week 12 through Week 24
Title
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
Description
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).
Time Frame
Up to Week 24
Title
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
Description
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Time Frame
Up to Week 12
Title
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
Description
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Time Frame
Week 12 through Week 24
Title
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
Description
Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated.
Time Frame
Up to Week 24
Title
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
Description
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Time Frame
Up to Week 12
Title
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
Description
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Time Frame
Week 12 through Week 24
Title
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
Description
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Time Frame
Up to Week 24
Title
Incidence of Hypercalcemia During Dosing Period 2
Description
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Time Frame
Week 12 through Week 24
Title
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
Description
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Time Frame
Up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Children's Hospital /ID# 225417
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Completed
Facility Name
Children's National Medical Center /ID# 225991
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2916
Country
United States
Individual Site Status
Recruiting
Facility Name
Holtz Childrens Hospital, University of Miami /ID# 225636
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1005
Country
United States
Individual Site Status
Recruiting
Facility Name
Nicklaus Children's Hospital /ID# 210517
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-3009
Country
United States
Individual Site Status
Completed
Facility Name
Emory University /ID# 140665
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1014
Country
United States
Individual Site Status
Completed
Facility Name
Boston Children's Hospital /ID# 162863
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Children's Specialty Center- Charlotte /ID# 216057
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-5866
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Philadelphia - Main /ID# 213802
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center /ID# 210495
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah /ID# 140669
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital /ID# 162861
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M11-617
Description
Related Info
Learn more about this trial
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)
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