A Phase 4 interventional study of Calcitriol and Paricalcitol in Kidney Failure, Secondary Hyperparathyroidism and Hyperphosphatemia, sponsored by Winthrop University Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Winthrop University Hospital · Phase 4, Interventional, and Treatment
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.
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Winthrop University Hospital is the lead sponsor of 42 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be excluded if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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: Calcitriol · Drug: Paricalcitol
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: Calcitriol · Drug: Paricalcitol
3 times weekly
Also known as: Calcijex®
3 times weekly
Also known as: Zemplar®
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
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
| Milestone | Calcitriol, Then Paricalcitol | Paricalcitol, Then Calcitriol |
|---|---|---|
| Started | 6 | 6 |
| Completed | 5 | 4 |
| Not completed | 1 | 2 |
| Withdrew: Kidney transplant | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| mg/dl | Calcitriol |
|---|---|
| Calcium Levels at Month 3 Post Calcitriol Treatment Initiation | 8.78 ± 0.332 |
| mg/dl | Paricalcitol |
|---|---|
| Calcium Levels at Month 3 Post Paricalcitol Treatment Initiation | 8.6 ± 0.3 |
| pg/dl | Calcitriol |
|---|---|
| PTH Levels at Month 3 Post Calcitriol Treatment Initiation | 309.58 ± 183.33 |
| pg/dl | Paricalcitol |
|---|---|
| PTH Levels at Month 3 Post Paricalcitol Treatment Initiation | 332.83 ± 146.9 |
| mg/dl | Calcitriol |
|---|---|
| Phosphorus Levels at Month 3 Post Calcitriol Initiation | 4.09 ± 0.71 |
| mg/dl | Paricalcitol |
|---|---|
| Phosphorus Levels at Month 3 Post Paricalcitol Initiation | 4.45 ± 1.18 |
| mcg | Calcitriol |
|---|---|
| Amount of Active Vitamin D Analog Used Through Month 3 Post Calcitriol Initiation | 36.9 ± 34.18 |
| mcg | Paricalcitol |
|---|---|
| Amount of Active Vitamin D Analog Used Through Month 3 Post Paricalcitol Initiation | 134.6 ± 87.35 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calcitriol | 0/9 (0%) | 1/9 (11.1%) | 0/9 (0%) |
| Paricalcitol | 0/9 (0%) | 2/9 (22.2%) | 0/9 (0%) |
| Event | Calcitriol | Paricalcitol |
|---|---|---|
| HematuriaRenal and urinary disorders | 1/9 | 1/9 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/9 | 1/9 |
Baseline characteristics are only available among participants who completed the trial.
| Age, Continuous(years) | Total Participants Who Completed Trial |
|---|---|
| Mean | 74.11 ± 5.57 |
| Sex: Female, Male(Participants) | Total Participants Who Completed Trial |
|---|---|
| Female | 2 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Total Participants Who Completed Trial |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Total Participants Who Completed Trial |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Total Participants Who Completed Trial |
|---|---|
| United States | 9 |
The record gives a start of Nov 2012, a primary completion of Dec 2013 and a completion of Oct 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2023, 9 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Calcitriol · Paricalcitol
Winthrop University Hospital