Phase 2
N=153
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Chronic Kidney Disease on Hemodialysis · Secondary Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00667576 ↗Enrolled (actual)
153
Serious AEs
6.5%
Results posted
Apr 2010
Primary outcome: Primary: Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level — 53.3; 41.9; 38.7; 56.7 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Maxacalcitol (Drug); Paricalcitol (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With ≥ 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level |
53.3; 41.9; 38.7; 56.7; 43.3 | — |
| SECONDARY Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level |
-233.2; -260.8; -178.2; -211.7; -236.6 | — |
| SECONDARY Percentage of Subjects With Intact Parathyroid Hormone (iPTH) ≤ 180 Picograms/Milliliter (pg/mL) |
36.7; 32.3; 32.3; 36.7; 33.3 | — |
| SECONDARY Percentage of Subjects With 2 or More Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level |
90.0; 100; 90.3; 90.0; 93.3 | — |
| SECONDARY Duration of 2 Consecutive Decreases of ≥ 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values |
23.8; 27.7; 29.0; 25.2; 10.9 | — |
| SECONDARY Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values ≤ 180 pg/mL |
22.0; 26.1; 19.7; 17.2; 3.1 | — |
Summary
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
- Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
- Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
- Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
- Phosphorus ≤ 6.5 mg/dL
- Age ≥ 20 years
Exclusion Criteria
- History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
- Parathyroidectomy or ethanol infusion within past year
- Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
- Drug or alcohol abuse within past 6 months
- Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
- Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Taking aluminum containing products (2 weeks prior to consent)
Data sourced from ClinicalTrials.gov (NCT00667576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.