Kidney FailurePhase 4ECRIPNCT01725113
Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
A Phase 4 study testing Calcitriol and Paricalcitol in people with Kidney Failure and Secondary Hyperparathyroidism, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Secondary Hyperparathyroidism, Hyperphosphatemia
- What is being tested?
- Calcitriol and Paricalcitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients
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.
Read the detailed description
Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients.
- Being tested
- Calcitriol, Paricalcitol
- Medical subject headings
- Renal Insufficiency, Hyperparathyroidism, Secondary, Hyperphosphatemia, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called Calcijex®
3 times weekly
ParicalcitolDrug
Also called Zemplar®
3 times weekly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Calcitriol; Drug: 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. Receives: Drug: Calcitriol; Drug: Paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium Levels at Month 3 Post Calcitriol Treatment Initiation
Measured: Up to Month 6
Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation
Measured: Up to Month 6
Secondary outcomes (6)
PTH Levels at Month 3 Post Calcitriol Treatment Initiation
Measured: Up to Month 6
PTH Levels at Month 3 Post Paricalcitol Treatment Initiation
Measured: Up to Month 6
Phosphorus Levels at Month 3 Post Calcitriol Initiation
Measured: Up to Month 6
Phosphorus Levels at Month 3 Post Paricalcitol Initiation
Measured: Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation
Measured: Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013
- Study completionOct 2015
Why it stopped: Nationwide shortage of study meds in 2013 loss of funding \& competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shayan Shirazian, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725113
- Sponsor's protocol ID
- 12027
- Acronym
- ECRIP
- Status last verified
- Oct 2023
- First submitted
- 7 Nov 2012
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01725113
- Acronym / sponsor ID
- ECRIP / 12027
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Nationwide shortage of study meds in 2013 loss of funding \& competing studies
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcitriol, then Paricalcitol | Experimental | Drug: Calcitriol, Drug: ParicalcitolPatients 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. |
| Paricalcitol, then Calcitriol | Active comparator | Drug: Calcitriol, Drug: ParicalcitolPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- age greater than 18
- active malignancy
- expected survival greater than 6 months
- high likelihood of renal transplant during the study period.
- Low calcium bath
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcitriolAlso: Calcijex®3 times weekly | Drug | Calcitriol, then Paricalcitol, Paricalcitol, then Calcitriol |
| ParicalcitolAlso: Zemplar®3 times weekly | Drug | Calcitriol, then Paricalcitol, Paricalcitol, then Calcitriol |
Primary outcome
Calcium Levels at Month 3 Post Calcitriol Treatment Initiation
Time frame: Up to Month 6
Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation
Time frame: Up to Month 6
6 secondary outcomes
PTH Levels at Month 3 Post Calcitriol Treatment Initiation
Time frame: Up to Month 6
PTH Levels at Month 3 Post Paricalcitol Treatment Initiation
Time frame: Up to Month 6
Phosphorus Levels at Month 3 Post Calcitriol Initiation
Time frame: Up to Month 6
Phosphorus Levels at Month 3 Post Paricalcitol Initiation
Time frame: Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation
Time frame: Up to Month 6
Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation
Time frame: Up to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shayan Shirazian, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcitriol and Paricalcitol in people with Kidney Failure and Secondary Hyperparathyroidism, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calcium Levels at Month 3 Post Calcitriol Treatment Initiation (time frame: Up to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.