NCT01725113

Brief Summary

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

November 7, 2012

Results QC Date

September 19, 2023

Last Update Submit

October 31, 2023

Conditions

Kidney FailureSecondary HyperparathyroidismHyperphosphatemiaHypercalcemia

Outcome Measures

Primary Outcomes (2)

  • Calcium Levels at Month 3 Post Calcitriol Treatment Initiation

    Up to Month 6

  • Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation

    Up to Month 6

Secondary Outcomes (6)

  • PTH Levels at Month 3 Post Calcitriol Treatment Initiation

    Up to Month 6

  • PTH Levels at Month 3 Post Paricalcitol Treatment Initiation

    Up to Month 6

  • Phosphorus Levels at Month 3 Post Calcitriol Initiation

    Up to Month 6

  • Phosphorus Levels at Month 3 Post Paricalcitol Initiation

    Up to Month 6

  • Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation

    Up to Month 6

  • +1 more secondary outcomes

Study Arms (2)

Calcitriol, then Paricalcitol

EXPERIMENTAL

Patients randomized to an active vitamin D treatment protocol based on IV calcitriol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV paricalcitol for 14 weeks.

Drug: CalcitriolDrug: Paricalcitol

Paricalcitol, then Calcitriol

ACTIVE COMPARATOR

Patients randomized to an active vitamin D treatment protocol based on IV paricalcitol. After 14 weeks, patients cross-over to an active vitamin D protocol based on IV calcitriol for 14 weeks.

Drug: CalcitriolDrug: Paricalcitol

Interventions

CalcitriolDRUG

3 times weekly

Also known as: Calcijex®
Calcitriol, then ParicalcitolParicalcitol, then Calcitriol
ParicalcitolDRUG

3 times weekly

Also known as: Zemplar®
Calcitriol, then ParicalcitolParicalcitol, then Calcitriol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All subjects will have been treated for at least three months on hemodialysis with IV paricalcitol. These subjects must have a most recent calcium level within the normal range, most recent phosphorus level \< 8 mg/dL and a most recent PTH between 130-585 pg/mL

You may not qualify if:

  • Patients will be excluded if:
  • age greater than 18
  • active malignancy
  • expected survival greater than 6 months
  • high likelihood of renal transplant during the study period.
  • Low calcium bath
  • prior parathyroidectomy
  • use of calcimimetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Renal InsufficiencyHyperparathyroidism, SecondaryHyperphosphatemiaHypercalcemia

Interventions

Calcitriolparicalcitol

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Candace Grant
Organization
NYU Langone Health
Candace.Grant@nyulangone.org
5166632171

Study Officials

  • Shayan Shirazian, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 12, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

October 1, 2015

Last Updated

November 7, 2023

Results First Posted

November 7, 2023

Record last verified: 2023-10

Locations

US(1)