Not provided
Not provided
Not provided
Not provided
Not provided
Company Decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Paricalcitol | Experimental | Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve Positive Response During Dosing Period 1 | 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). | Up to Week 12 |
| Incidence of Hypercalcemia During Dosing Period 1 | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | Up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a Positive Response During Dosing Period 2 | 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). | Week 12 through Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital /ID# 225417 | Little Rock | Arkansas | 72202 | United States | ||
| Stanford University School of Medicine - Redwood City /ID# 252150 |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Paricalcitol | Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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 13, 2023 | May 19, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined |
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). |
| Up to Week 24 |
| Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1 | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | Up to Week 12 |
| Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2 | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | Week 12 through Week 24 |
| Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | Up to Week 24 |
| 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | Up to Week 12 |
| 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | Week 12 through Week 24 |
| 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | Up to Week 24 |
| Incidence of Hypercalcemia During Dosing Period 2 | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | Week 12 through Week 24 |
| Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | Up to Week 24 |
| Redwood City |
| California |
| 94063 |
| United States |
| Childrens National Medical Center /ID# 225991 | Washington D.C. | District of Columbia | 20010-2916 | United States |
| Holtz Childrens Hospital, University of Miami /ID# 225636 | Miami | Florida | 33136-1005 | United States |
| Nicklaus Children's Hospital /ID# 210517 | Miami | Florida | 33155-3009 | United States |
| Emory University /ID# 140665 | Atlanta | Georgia | 30322-1014 | United States |
| Augusta University Medical Center /ID# 252149 | Augusta | Georgia | 30912-0004 | United States |
| Boston Children's Hospital /ID# 162863 | Boston | Massachusetts | 02115 | United States |
| Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057 | Charlotte | North Carolina | 28203-5866 | United States |
| Atrium Health Wake Forest Baptist Medical Center /ID# 266045 | Winston-Salem | North Carolina | 27157 | United States |
| Children's Hospital of Philadelphia - Main /ID# 213802 | Philadelphia | Pennsylvania | 19104-4319 | United States |
| University of Texas Southwestern Medical Center /ID# 210495 | Dallas | Texas | 75390-7208 | United States |
| University of Utah /ID# 140669 | Salt Lake City | Utah | 84112-5500 | United States |
| Seattle Children's Hospital /ID# 162861 | Seattle | Washington | 98105 | United States |
| School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663 | San Juan | 00935 | Puerto Rico |
| Dosing Period 1 |
|
| Dosing Period 2 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Paricalcitol | Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | 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 Achieve Positive Response During Dosing Period 1 | 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). | Posted | Number | percentage of participants | Up to Week 12 |
|
|
| |||||||||||||||||||||||||||
| Primary | Incidence of Hypercalcemia During Dosing Period 1 | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | Posted | Count of Participants | Participants | Up to Week 12 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve a Positive Response During Dosing Period 2 | 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). | One subject prematurely discontinued during Period 1. | Posted | Number | percentage of participants | Week 12 through Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined | 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). | Posted | Number | percentage of participants | Up to Week 24 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1 | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | Posted | Number | percentage of participants | Up to Week 12 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2 | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | One subject prematurely discontinued during Period 1. | Posted | Number | percentage of participants | Week 12 through Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined | Participants who achieve two consecutive >= 30% reductions in iPTH will be evaluated. | Posted | Number | percentage of participants | Up to Week 24 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | Posted | Number | percentage of participants | Up to Week 12 |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | One subject prematurely discontinued during Period 1. | Posted | Number | percentage of participants | Week 12 through Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated. | Posted | Number | percentage of participants | Up to Week 24 |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Hypercalcemia During Dosing Period 2 | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | One subject prematurely discontinued during Period 1. | Posted | Count of Participants | Participants | Week 12 through Week 24 |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined | Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit. | Posted | Count of Participants | Participants | Up to Week 24 |
|
|
All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1.
None of the SAEs were related to study drug.
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 | Participants Receiving Paricalcitol | Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser | 0 | 2 | 2 | 2 | 1 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEVICE RELATED BACTERAEMIA | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| HYPERNATRAEMIA | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| TONIC CONVULSION | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GASTROINTESTINAL INFLAMMATION | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| VANCOMYCIN INFUSION REACTION | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2025 | May 19, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C084656 | paricalcitol |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|