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Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

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ClinicalTrials.gov Identifier: NCT02859896
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 9, 2016
Last Update Posted Date October 31, 2019
Actual Study Start Date  ICMJE January 19, 2017
Estimated Primary Completion Date April 5, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
Percentage of participants achieving two consecutive ≥30% reductions in iPTH [ Time Frame: Baseline up to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02859896 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2016)
  • Percentage change from baseline in iPTH [ Time Frame: Baseline, Week 12, Week 24 ]
  • Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL) [ Time Frame: Up to Weeks 12 and 24 ]
  • Number of participants with adverse events [ Time Frame: Baseline up to Week 24 ]
  • Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data [ Time Frame: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Official Title  ICMJE An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Brief Summary

Primary Objective:

Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).

Secondary Objectives:

  • Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.
  • Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Detailed Description The total study duration per patient will be approximately up to 28 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Secondary Hyperparathyroidism-Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Doxercalciferol (GZ427397)

    Pharmaceutical form: capsule

    Route of administration: oral

    Other Name: Hectorol
  • Drug: Calcitriol

    Pharmaceutical form: capsule

    Route of administration: oral

    Other Name: Rocaltrol
Study Arms  ICMJE
  • Experimental: Hectorol
    Hectorol (Doxercalciferol) will be administered orally two to three times weekly dependent on patient age. A dose titration scheme is used to individualize the dose to the patient's iPTH management.
    Intervention: Drug: Doxercalciferol (GZ427397)
  • Active Comparator: Rocaltrol
    Rocaltrol (Calcitriol) will be administered orally seven days/week. A dose titration scheme is used to individualize the dose to the patient's iPTH management.
    Intervention: Drug: Calcitriol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2016)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 5, 2022
Estimated Primary Completion Date April 5, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria :

  • Male or female aged 5 to 18 years old.
  • Weight ≥15 kg.
  • Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 (established by Schwartz equation) at Week -2 visit.
  • Intact parathyroid hormone (iPTH) value >100 pg/mL for CKD Stage 3 or >160 pg/mL for CKD Stage 4, at Week -2 visit.
  • Signed informed consent/assent form.

Exclusion criteria:

  • The patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
  • The patient has a corrected calcium ≥10 mg/dL at the Week -2 visit.
  • The patient has a serum phosphorus >4.5 mg/dL for children 13 to 18 years of age; >5.8 mg/dL for children 5 to 12 years of age at the Week -2 visit.
  • The patient is anticipated to require maintenance hemodialysis within 3 months.
  • The patient used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
  • The patient has a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit.
  • The patient currently has a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy).
  • The patient currently has primary hyperparathyroidism or has had a total parathyroidectomy.
  • The patient has an active malignancy.
  • The patient is unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.
  • The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs.
  • The patient currently uses aluminum or magnesium-based binders.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-Us@sanofi.com
Listed Location Countries  ICMJE Chile,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT02859896
Other Study ID Numbers  ICMJE LPS14314
U1111-1178-4657 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP