Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-23 @ 6:24 AM
Study NCT ID:
NCT04064827
Status:
TERMINATED
Last Update Posted:
2025-12-04
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C084656', 'term': 'paricalcitol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Company Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-20', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve Positive Response During Dosing Period 1', 'timeFrame': 'Up to Week 12', 'description': '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).'}, {'measure': 'Incidence of Hypercalcemia During Dosing Period 1', 'timeFrame': 'Up to Week 12', 'description': "Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve a Positive Response During Dosing Period 2', 'timeFrame': 'Week 12 through Week 24', 'description': '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).'}, {'measure': 'Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined', 'timeFrame': 'Up to Week 24', 'description': '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).'}, {'measure': 'Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1', 'timeFrame': 'Up to Week 12', 'description': 'Participants who achieve two consecutive \\>= 30% reductions in iPTH will be evaluated.'}, {'measure': 'Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2', 'timeFrame': 'Week 12 through Week 24', 'description': 'Participants who achieve two consecutive \\>= 30% reductions in iPTH will be evaluated.'}, {'measure': 'Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined', 'timeFrame': 'Up to Week 24', 'description': 'Participants who achieve two consecutive \\>= 30% reductions in iPTH will be evaluated.'}, {'measure': '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', 'timeFrame': 'Up to Week 12', 'description': 'Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.'}, {'measure': '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', 'timeFrame': 'Week 12 through Week 24', 'description': 'Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.'}, {'measure': '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', 'timeFrame': 'Up to Week 24', 'description': 'Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.'}, {'measure': 'Incidence of Hypercalcemia During Dosing Period 2', 'timeFrame': 'Week 12 through Week 24', 'description': "Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit."}, {'measure': 'Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined', 'timeFrame': 'Up to Week 24', 'description': "Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Paricalcitol', 'Hyperparathyroidism', 'Pediatric Subjects', 'Peritoneal Dialysis (PD)', 'Hemodialysis (HD)', 'Intact parathyroid hormone (iPTH)'], 'conditions': ['Chronic Kidney Disease (CKD)', 'Secondary Hyperparathyroidism (SHPT)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M11-617', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).\n* 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.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.\n* Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.\n* Participant has had a parathyroidectomy within 12 weeks prior to Screening.\n* 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.\n* Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.\n* Participant is unable to take oral medications."}, 'identificationModule': {'nctId': 'NCT04064827', 'briefTitle': '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)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M11-617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants Receiving Paricalcitol', 'description': 'Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks', 'interventionNames': ['Drug: Paricalcitol']}], 'interventions': [{'name': 'Paricalcitol', 'type': 'DRUG', 'description': 'Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser', 'armGroupLabels': ['Participants Receiving Paricalcitol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital /ID# 225417", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine - Redwood City /ID# 252150', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '20010-2916', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Medical Center /ID# 225991', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33136-1005', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Holtz Childrens Hospital, University of Miami /ID# 225636', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155-3009', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital /ID# 210517", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30322-1014', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University /ID# 140665', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912-0004', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center /ID# 252149', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital /ID# 162863", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '28203-5866', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Wake Forest Baptist Medical Center /ID# 266045', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19104-4319', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia - Main /ID# 213802", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75390-7208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center /ID# 210495', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112-5500', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah /ID# 140669', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital /ID# 162861", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/abbvie/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}