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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Secondary Hyperparathyroidism-Chronic Kidney Disease	Drug: Doxercalciferol (GZ427397) Other Names Hectorol Drug: Calcitriol Other Names Rocaltrol	Phase 3

Tracking Information

First Submitted Date	August 04, 2016
Last Update Posted Date	February 22, 2018
Actual Start Date	January 19, 2017
Anticipated Completion Date	April 02, 2020
Actual Primary Completion Date	December 27, 2019
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Percentage of participants achieving two consecutive ≥30% reductions in iPTH [Time Frame: Baseline up to Week 12]

Original Primary Outcome Measures

Current Secondary Outcome Measures

• 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

Study Design

Brief Title	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	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	Interventional
Study Phase	Phase 3
Estimated Enrollment	84
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Conditions	Secondary Hyperparathyroidism-Chronic Kidney Disease
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: Doxercalciferol (GZ427397) Pharmaceutical form: capsule Route of administration: oral Other Names Hectorol Drug: Calcitriol Pharmaceutical form: capsule Route of administration: oral Other Names Rocaltrol
Study Groups/Cohorts	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. 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.
Study Arms	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. Drug : Doxercalciferol (GZ427397) Pharmaceutical form: capsule Route of administration: oral 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. Drug : Calcitriol Pharmaceutical form: capsule Route of administration: oral

Arm	Intervention/Treatment
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.	Drug : Doxercalciferol (GZ427397) Pharmaceutical form: capsule Route of administration: oral
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.	Drug : Calcitriol Pharmaceutical form: capsule Route of administration: oral

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	84
Completion Date	April 02, 2020
Eligibility Criteria:	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.
Gender	All
Age	5 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts	For site information, send an email with site number to [email protected]
Listed Location Countries	Chile United States Argentina

Administrative Information

NCT Number:	NCT02859896
Other Study ID Numbers	LPS14314 U1111-1178-4657
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 Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Sanofi
Collaborators	Not Available
Investigators	Study Director Clinical Sciences & Operations Sanofi