---
title: A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
nct_id: NCT04064827
overall_status: TERMINATED
phase: PHASE3
sponsor: AbbVie
study_type: INTERVENTIONAL
primary_condition: Chronic Kidney Disease (CKD)
countries: United States, Puerto Rico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04064827.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04064827"
ct_last_update_post_date: 2025-12-04
last_seen_at: "2026-05-12T06:16:47.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

**Official Title:** A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

**NCT ID:** [NCT04064827](https://clinicaltrials.gov/study/NCT04064827)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Company Decision
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 2
- **Lead Sponsor:** AbbVie
- **Conditions:** Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)
- **Start Date:** 2020-09-16
- **Completion Date:** 2025-06-09
- **CT.gov Last Update:** 2025-12-04

## Brief Summary

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).

## Eligibility

- **Minimum age:** 0 Years
- **Maximum age:** 9 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
* Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
* For entry into the Washout Period (for vitamin D receptor activator \[VDRA\] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
* For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.

Exclusion Criteria:

* Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
* Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
* Participant has had a parathyroidectomy within 12 weeks prior to Screening.
* Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than \> 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
* Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
* Participant is unable to take oral medications.
```

## Arms

- **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

## Interventions

- **Paricalcitol** (DRUG) — Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

## Primary Outcomes

- **Percentage of Participants Who Achieve Positive Response During Dosing Period 1** _(time frame: Up to Week 12)_ — 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).
- **Incidence of Hypercalcemia During Dosing Period 1** _(time frame: Up to Week 12)_ — Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

## Secondary Outcomes

- **Percentage of Participants Who Achieve a Positive Response During Dosing Period 2** _(time frame: Week 12 through Week 24)_
- **Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined** _(time frame: Up to Week 24)_
- **Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1** _(time frame: Up to Week 12)_
- **Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2** _(time frame: 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** _(time frame: 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** _(time frame: 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** _(time frame: 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** _(time frame: Up to Week 24)_
- **Incidence of Hypercalcemia During Dosing Period 2** _(time frame: Week 12 through Week 24)_
- **Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined** _(time frame: Up to Week 24)_

## Locations (15)

- Arkansas Children's Hospital /ID# 225417, Little Rock, Arkansas, United States
- Stanford University School of Medicine - Redwood City /ID# 252150, Redwood City, California, United States
- Childrens National Medical Center /ID# 225991, Washington D.C., District of Columbia, United States
- Holtz Childrens Hospital, University of Miami /ID# 225636, Miami, Florida, United States
- Nicklaus Children's Hospital /ID# 210517, Miami, Florida, United States
- Emory University /ID# 140665, Atlanta, Georgia, United States
- Augusta University Medical Center /ID# 252149, Augusta, Georgia, United States
- Boston Children's Hospital /ID# 162863, Boston, Massachusetts, United States
- Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057, Charlotte, North Carolina, United States
- Atrium Health Wake Forest Baptist Medical Center /ID# 266045, Winston-Salem, North Carolina, United States
- Children's Hospital of Philadelphia - Main /ID# 213802, Philadelphia, Pennsylvania, United States
- University of Texas Southwestern Medical Center /ID# 210495, Dallas, Texas, United States
- University of Utah /ID# 140669, Salt Lake City, Utah, United States
- Seattle Children's Hospital /ID# 162861, Seattle, Washington, United States
- School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663, San Juan, Puerto Rico

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `locations.emory university /id# 140665|atlanta|georgia|united states` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.arkansas children's hospital /id# 225417|little rock|arkansas|united states` — added _(2026-05-12)_
- `locations.stanford university school of medicine - redwood city /id# 252150|redwood city|california|united states` — added _(2026-05-12)_
- `locations.childrens national medical center /id# 225991|washington d.c.|district of columbia|united states` — added _(2026-05-12)_
- `locations.holtz childrens hospital, university of miami /id# 225636|miami|florida|united states` — added _(2026-05-12)_
- `locations.nicklaus children's hospital /id# 210517|miami|florida|united states` — added _(2026-05-12)_
- `locations.augusta university medical center /id# 252149|augusta|georgia|united states` — added _(2026-05-12)_
- `locations.boston children's hospital /id# 162863|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.duplicate_levine children's specialty center- charlotte /id# 216057|charlotte|north carolina|united states` — added _(2026-05-12)_
- `locations.atrium health wake forest baptist medical center /id# 266045|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `locations.children's hospital of philadelphia - main /id# 213802|philadelphia|pennsylvania|united states` — added _(2026-05-12)_
- `locations.university of texas southwestern medical center /id# 210495|dallas|texas|united states` — added _(2026-05-12)_
- `locations.university of utah /id# 140669|salt lake city|utah|united states` — added _(2026-05-12)_
- `locations.seattle children's hospital /id# 162861|seattle|washington|united states` — added _(2026-05-12)_
- `locations.school of medicine university of puerto rico-medical science campus /id# 140663|san juan||puerto rico` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04064827.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04064827*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*