Secondary Hyperparathyroidism-Chronic Kidney DiseasePhase 3NCT02859896
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
A Phase 3 study testing Doxercalciferol (GZ427397) and Calcitriol in people with Secondary Hyperparathyroidism-Chronic Kidney Disease, run by Sanofi at 23 sites in 2 countries.
Trial summary
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Secondary Hyperparathyroidism-Chronic Kidney Disease
- What is being tested?
- Doxercalciferol (GZ427397) and Calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 19 Jan 2017to 11 Jun 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- The participant had a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
- The participant had a corrected calcium ≥10 mg/dL at the Week -2 visit.
- The participant had 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 participant was anticipated to require maintenance hemodialysis within 3 months.
- The participant used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
- The participant had a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit.
Show all 13Show fewer
- The participant had a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy).
- The participant had primary hyperparathyroidism or has had a total parathyroidectomy.
- The participant had an active malignancy.
- The participant was unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules.
- The participant had a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs.
- The participant used aluminum or magnesium-based binders.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States21 sites
Children's of Alabama- Site Number : 8400022
Birmingham, Alabama, 35233
Rush University Medical Center- Site Number : 8400020
Chicago, Illinois, 60612
Duke University Medical Center- Site Number : 8400034
Durham, North Carolina, 27710
East Carolina University- Site Number : 8400025
Greenville, North Carolina, 27858
Greenville Memorial Hospital- Site Number : 8400027
Greenville, South Carolina, 29605
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010
Hackensack, New Jersey, 07601
Texas Children's Hospital- Site Number : 8400013
Houston, Texas, 77030
Cedars-Sinai Medical Center- Site Number : 8400033
Los Angeles, California, 90048
Marshfield Medical Center - Marshfield- Site Number : 8400001
Marshfield, Wisconsin, 54449
University of Miami Hospital- Site Number : 8400006
Miami, Florida, 33136
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008
Miami, Florida, 33155
M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014
Minneapolis, Minnesota, 55454
Goryeb Chidlren's Hospital- Site Number : 8400016
Morristown, New Jersey, 07962
Vanderbilt University Medical Center- Site Number : 8400024
Nashville, Tennessee, 37292
Yale University School of Medicine- Site Number : 8400029
New Haven, Connecticut, 06510
Cohen Children's Medical Center- Site Number : 8400017
New Hyde Park, New York, 11040
The Mount Sinai Hospital- Site Number : 8400007
New York, New York, 10029
UPMC Children's Hospital of Pittsburgh- Site Number : 8400028
Pittsburgh, Pennsylvania, 15224
Virginia Commonwealth University Medical Center- Site Number : 8400009
Richmond, Virginia, 23219
University of California Davis Health- Site Number : 8400005
Sacramento, California, 95817
University of Utah Health Hospital- Site Number : 8400026
Salt Lake City, Utah, 84132
Chile2 sites
Investigational Site Number : 1520004
Concepción, Biobio, 4070038
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7500539
About this study
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
Primary Objective:
Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).
Secondary Objectives:
- Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.
- Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Read the detailed description
The total study duration per participant was approximately up to 28 weeks.
- Being tested
- Doxercalciferol (GZ427397), Calcitriol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxercalciferol (GZ427397)Drug
Also called Hectorol
Pharmaceutical form: capsule
Route of administration: oral
CalcitriolDrug
Also called Rocaltrol
Pharmaceutical form: capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Hectorol | Experimental | Hectorol (Doxercalciferol) was administered orally two to three times weekly dependent on participant age. A dose titration scheme was used to individualize the dose to the participant's iPTH management. Receives: Drug: Doxercalciferol (GZ427397) |
| Rocaltrol | Active comparator | Rocaltrol (Calcitriol) was administered orally seven days/week. A dose titration scheme was used to individualize the dose to the participant's iPTH management. Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
Blood samples were collected for assessment of iPTH levels. The percentage of participants meeting the iPTH >=30% reduction from baseline at 2 consecutive study visits up to Week 12 was calculated. Two consecutive >=30% reductions in iPTH from baseline up to Week 12 was defined as two consecutive 30% or greater reductions at any two consecutive measurements from baseline up to Week 12 with on-treatment strategy applied. The confidence interval (CI) was estimated using Clopper-Pearson method. The baseline value is defined as the last available value before the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Measured: Baseline (Day 1) up to Week 12
Secondary outcomes (7)
Percent Change in Intact Parathyroid Hormone From Baseline to Weeks 12 and 24
Blood samples were collected for assessment of iPTH levels. The percentage changes from baseline iPTH, the effects over the treatment period time was explored using a mixed model for repeated measures approach (MMRM) as appropriate. The baseline value is defined as the last available value before the first dose of study treatment.
Measured: Baseline (Day 1) to Weeks 12 and 24
Number of Hypercalcemia Events up to Weeks 12 and 24
Hypercalcemia was defined as albumin corrected serum calcium >10.2 milligrams per deciliter (mg/dL). Here, data for number of hypercalcemia events are reported.
Measured: Up to Weeks 12 and 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE occurred or was detected from the date the participant signed the informed consent form, irrespective of study periods without administration of the study treatment. TEAEs were defined as the AEs that developed, worsened or became serious during the treatment-emergent period (defined as time from administration of study treatment [Day 1] to last administration of study treatment + 4 days). SAE: Any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Measured: From first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks
Maximum Observed Plasma Concentration (Cmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine Cmax. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol pharmacokinetic (PK) parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Measured: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Time to Maximum Plasma Concentration (Tmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine tmax. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Measured: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine AUC0-24h. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Measured: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Trough Plasma Concentration (Ctrough) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine Ctrough. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Measured: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start19 Jan 2017
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Why it stopped: The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary Hyperparathyroidism-Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859896
- Sponsor's protocol ID
- LPS14314
- Other IDs
- U1111-1178-4657
- Status last verified
- Jun 2026
- First submitted
- 4 Aug 2016
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02859896
- Acronym / sponsor ID
- LPS14314
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).
Secondary Objectives:
- Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.
- Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
Detailed description
The total study duration per participant was approximately up to 28 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hectorol | Experimental | Drug: Doxercalciferol (GZ427397)Hectorol (Doxercalciferol) was administered orally two to three times weekly dependent on participant age. A dose titration scheme was used to individualize the dose to the participant's iPTH management. |
| Rocaltrol | Active comparator | Drug: CalcitriolRocaltrol (Calcitriol) was administered orally seven days/week. A dose titration scheme was used to individualize the dose to the participant's iPTH management. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- The participant had a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
- The participant had a corrected calcium ≥10 mg/dL at the Week -2 visit.
- The participant had 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 participant was anticipated to require maintenance hemodialysis within 3 months.
- The participant used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxercalciferol (GZ427397)Also: HectorolPharmaceutical form: capsule Route of administration: oral | Drug | Hectorol |
| CalcitriolAlso: RocaltrolPharmaceutical form: capsule Route of administration: oral | Drug | Rocaltrol |
Primary outcome
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
Time frame: Baseline (Day 1) up to Week 12
Blood samples were collected for assessment of iPTH levels. The percentage of participants meeting the iPTH >=30% reduction from baseline at 2 consecutive study visits up to Week 12 was calculated. Two consecutive >=30% reductions in iPTH from baseline up to Week 12 was defined as two consecutive 30% or greater reductions at any two consecutive measurements from baseline up to Week 12 with on-treatment strategy applied. The confidence interval (CI) was estimated using Clopper-Pearson method. The baseline value is defined as the last available value before the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
7 secondary outcomes
Percent Change in Intact Parathyroid Hormone From Baseline to Weeks 12 and 24
Time frame: Baseline (Day 1) to Weeks 12 and 24
Number of Hypercalcemia Events up to Weeks 12 and 24
Time frame: Up to Weeks 12 and 24
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks
Maximum Observed Plasma Concentration (Cmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Time frame: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Time to Maximum Plasma Concentration (Tmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Time frame: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Time frame: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Trough Plasma Concentration (Ctrough) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
Time frame: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Doxercalciferol (GZ427397) and Calcitriol in people with Secondary Hyperparathyroidism-Chronic Kidney Disease, run by Sanofi at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12 (time frame: Baseline (Day 1) up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.