Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1178-4657 | Registry Identifier | ICTRP |
Not provided
Not provided
Not provided
The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.
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Primary Objective:
Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).
Secondary Objectives:
The total study duration per participant was approximately up to 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxercalciferol (GZ427397) | Drug | Pharmaceutical form: capsule Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1) up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama- Site Number : 8400022 | Birmingham | Alabama | 35233 | United States | ||
| Cedars-Sinai Medical Center- Site Number : 8400033 |
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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A total of 21 participants were randomized in a 2:1 ratio to receive either doxercalciferol (Hectorol®) or calcitriol (Rocaltrol®). The study was conducted to fulfill a post-marketing commitment (PMC). The study was terminated as food and drug administration (FDA) acknowledged the fulfillment of this PMC on 11 June 2025.
Note: Reason for not completed = Reason for permanent treatment discontinuation.
The study was conducted at 23 centers in 2 countries. A total of 59 participants were screened from 19 January 2017 to 05 February 2020, of which 38 were screen failures. Screen failures were mainly due to participants did not meet the inclusion/exclusion criteria of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Doxercalciferol (Hectorol®) | Participants were administered doxercalciferol (Hectorol®) one 0.5 microgram (μg) capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's intact parathyroid hormone (iPTH) management. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Jun 8, 2026 |
Not provided
Not provided
Not provided
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| Calcitriol | Drug | Pharmaceutical form: capsule Route of administration: oral |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10 |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California Davis Health- Site Number : 8400005 | Sacramento | California | 95817 | United States |
| Yale University School of Medicine- Site Number : 8400029 | New Haven | Connecticut | 06510 | United States |
| University of Miami Hospital- Site Number : 8400006 | Miami | Florida | 33136 | United States |
| Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008 | Miami | Florida | 33155 | United States |
| Rush University Medical Center- Site Number : 8400020 | Chicago | Illinois | 60612 | United States |
| M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014 | Minneapolis | Minnesota | 55454 | United States |
| Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010 | Hackensack | New Jersey | 07601 | United States |
| Goryeb Chidlren's Hospital- Site Number : 8400016 | Morristown | New Jersey | 07962 | United States |
| Cohen Children's Medical Center- Site Number : 8400017 | New Hyde Park | New York | 11040 | United States |
| The Mount Sinai Hospital- Site Number : 8400007 | New York | New York | 10029 | United States |
| Duke University Medical Center- Site Number : 8400034 | Durham | North Carolina | 27710 | United States |
| East Carolina University- Site Number : 8400025 | Greenville | North Carolina | 27858 | United States |
| UPMC Children's Hospital of Pittsburgh- Site Number : 8400028 | Pittsburgh | Pennsylvania | 15224 | United States |
| Greenville Memorial Hospital- Site Number : 8400027 | Greenville | South Carolina | 29605 | United States |
| Vanderbilt University Medical Center- Site Number : 8400024 | Nashville | Tennessee | 37292 | United States |
| Texas Children's Hospital- Site Number : 8400013 | Houston | Texas | 77030 | United States |
| University of Utah Health Hospital- Site Number : 8400026 | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University Medical Center- Site Number : 8400009 | Richmond | Virginia | 23219 | United States |
| Marshfield Medical Center - Marshfield- Site Number : 8400001 | Marshfield | Wisconsin | 54449 | United States |
| Investigational Site Number : 1520004 | Concepción | Biobio | 4070038 | Chile |
| Investigational Site Number : 1520003 | Santiago | Reg Metropolitana de Santiago | 7500539 | Chile |
| Calcitriol (Rocaltrol®) |
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized population consisted of all participants randomized either into the doxercalciferol (Hectorol®) or calcitriol (Rocaltrol®) group.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Doxercalciferol (Hectorol®) | Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. |
| BG001 | Calcitriol (Rocaltrol®) | Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full analysis set (FAS) consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) up to Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment. | Posted | Least Squares Mean | Standard Error | percent change | Baseline (Day 1) to Weeks 12 and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | FAS consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment. | Posted | Number | hypercalcemia events | Up to Weeks 12 and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Safety population consisted of all randomized participants who had taken at least one dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported. | Posted | Median | Full Range | hours | Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | hours*pg/mL | Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | pg/mL | Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10 |
|
|
Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doxercalciferol (Hectorol®) | Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. | 0 | 14 | 3 | 14 | 11 | 14 |
| EG001 | Calcitriol (Rocaltrol®) | Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. | 0 | 7 | 0 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Urgency | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| End Stage Renal Disease | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Tinea Versicolour | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Periorbital Swelling | Eye disorders | MedDra 25.0 | Systematic Assessment |
| |
| Ear Pain | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Mouth Ulceration | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Adjusted Calcium Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Blood Parathyroid Hormone Decreased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Blood Phosphorus Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Body Temperature Increased | Investigations | MedDra 25.0 | Systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Stoma Site Haemorrhage | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
|
The study was conducted to fulfill a PMC. The study was terminated as FDA acknowledged the fulfillment of this PMC on 11 June 2025.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 13, 2022 | Jun 8, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
| Black or African American |
|
| White/Black or African American |
|
| Not reported |
|
| Unknown |
|
| Counts |
|---|
| Participants |
|
|
|
| OG001 | Calcitriol (Rocaltrol®) | Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management. |
|
|
|
|
|
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