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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064827
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

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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 : January 16, 2020
Estimated Primary Completion Date : March 9, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064827


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
University of California, Los Angeles /ID# 140668 Not yet recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Colorado Children's Hospital /ID# 162862 Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Nicklaus Children's Hospital /ID# 210517 Not yet recruiting
Miami, Florida, United States, 33155-3009
United States, Georgia
Emory University Hospital /ID# 140665 Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Childrens Hospital /ID# 162863 Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
Childrens Mercy Hosp and Clin /ID# 140672 Not yet recruiting
Kansas City, Missouri, United States, 64108
United States, North Carolina
Levine Children's Specialty Center- Charlotte /ID# 216057 Not yet recruiting
Charlotte, North Carolina, United States, 28203-5866
United States, Texas
UT Southwestern Medical Center /ID# 210495 Not yet recruiting
Dallas, Texas, United States, 75390-7208
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 Sciences Campus /ID# 140663 Recruiting
San Juan, Puerto Rico, 00935
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04064827    
Other Study ID Numbers: M11-617
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
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 and 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)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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 (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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