Secondary HyperparathyroidismPhase 4PACENCT00823303
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
A Phase 4 study testing Paricalcitol and Calcitriol in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Washington University School of Medicine at 4 sites in United States.
Trial summary
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- What is being tested?
- Paricalcitol and Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2009to Sep 2013
- 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
- Age >18; Able to give informed consent
- Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
- intact PTH (iPTH) >120 pg/ml at baseline
- albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline
- Phosphorus < 4.6 mg/dL at baseline
- If on a phosphorus binder; no change in dose within the 4 weeks prior to screening
Who cannot join
- Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
- Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
- history of primary HPT
- On prednisone > 30 days within the previous 6 months
- receiving bisphosphonates or calcitonin within the previous 12 months
- Non-elective hospitalization within the previous 30 days.
Show all 13Show fewer
- Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
- History of renal or other organ transplant
- History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
- Receiving cinacalcet within 4 weeks prior to screening.
- An active drug/alcohol dependence or abuse history
- History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
- Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University
Chicago, Illinois, 60611
Henry Ford Hospital
Detroit, Michigan, 48202
Northshore University Health System
Evanston, Illinois, 60201
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
Read the detailed description
General Design
- Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
- Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
- Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.
- Being tested
- Paricalcitol, Calcitriol
- Keywords
- PTH, Active Vitamin D, hypercalcemia, Chronic Kidney Disease
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Zemplar
1 mcg daily, adjusted to achieve 40-60% PTH suppression
CalcitriolDrug
Also called Rocaltrol
0.25 mcg daily, adjusted to achieve 40-60% PTH suppression
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | titrated to achieve 40-60% PTH suppression Receives: Drug: Paricalcitol |
| Calcitriol | Active comparator | titrated to achieve 40-60% PTH suppression Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Hypercalcemia
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Measured: 24 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2013
- Study completionSep 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Hospital, Northwestern University, Endeavor Health, Abbott
- Responsible party
- Principal investigator, Daniel W. Coyne, Washington University School of Medicine
- Investigators
- Daniel W Coyne, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823303
- Sponsor's protocol ID
- 22095
- Acronym
- PACE
- Status last verified
- Aug 2014
- First submitted
- 12 Dec 2008
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Coyne DW, Goldberg S, Faber M, Ghossein C, Sprague SM. A randomized multicenter trial of paricalcitol versus calcitriol for secondary hyperparathyroidism in stages 3-4 CKD. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1620-6. doi: 10.2215/CJN.10661013. Epub 2014 Jun 26.
PubMed 24970869
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT00823303
- Acronym / sponsor ID
- PACE / 22095
- Keywords
- PTH, Active Vitamin D, hypercalcemia, Chronic Kidney Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Henry Ford Hospital, Northwestern University, Endeavor Health, Abbott
- Study start
- Feb 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Posted 5 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.
Detailed description
General Design
- Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
- Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
- Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: Paricalcitoltitrated to achieve 40-60% PTH suppression |
| Calcitriol | Active comparator | Drug: Calcitrioltitrated to achieve 40-60% PTH suppression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18; Able to give informed consent
- Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
- intact PTH (iPTH) >120 pg/ml at baseline
- albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline
- Phosphorus < 4.6 mg/dL at baseline
Key exclusion criteria (13 listed)
- Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
- Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.
- history of primary HPT
- On prednisone > 30 days within the previous 6 months
- receiving bisphosphonates or calcitonin within the previous 12 months
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 |
|---|---|---|
| ParicalcitolAlso: Zemplar1 mcg daily, adjusted to achieve 40-60% PTH suppression | Drug | Paricalcitol |
| CalcitriolAlso: Rocaltrol0.25 mcg daily, adjusted to achieve 40-60% PTH suppression | Drug | Calcitriol |
Primary outcome
Confirmed Hypercalcemia
Time frame: 24 week treatment period
Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24970869Coyne DW, Goldberg S, Faber M, Ghossein C, Sprague SM. A randomized multicenter trial of paricalcitol versus calcitriol for secondary hyperparathyroidism in stages 3-4 CKD. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1620-6. doi: 10.2215/CJN.10661013. Epub 2014 Jun 26.
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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.
Daniel W Coyne, MD principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paricalcitol and Calcitriol in people with Secondary Hyperparathyroidism and Chronic Kidney Disease, run by Washington University School of Medicine at 4 sites 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 5 Aug 2014). 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?
Confirmed Hypercalcemia (time frame: 24 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823303, which also lists 1 linked publication.
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 Aug 2014.