Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
paricalcitol · 4 trials · 6 indications
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L).
The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.
The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.
The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)\^2.7.
| Arm | Type | Description |
|---|---|---|
| Paricalcitol | EXPERIMENTAL | Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. |
| Maxacalcitol | ACTIVE_COMPARATOR | Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. |
| Part 1: Paricalcitol | EXPERIMENTAL | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. |
| Part 2: Paricalcitol | EXPERIMENTAL | Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. |
| Placebo | PLACEBO_COMPARATOR | Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period. |
| Name | Type | Description |
|---|---|---|
| paricalcitol | DRUG | Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels. |
| maxacalcitol | DRUG | - |
| paricalcitol placebo | DRUG | - |
| maxacalcitol placebo | DRUG | - |
| Placebo | DRUG | Placebo capsules taken with water |
Inclusion Criteria: * Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening * Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism * For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor ...
Paricalcitol is used for secondary hyperparathyroidism in chronic kidney disease, including end-stage renal disease and chronic kidney disease stages 3 and 4. It is a small molecule being developed by AbbVie Inc. for nephrology indications.
Paricalcitol is a vitamin D analog that targets the vitamin D receptor. It works by decreasing serum parathyroid hormone levels in patients with chronic kidney disease, as shown in clinical trials.
Paricalcitol is developed by AbbVie Inc., traded as ABBV on the stock exchange. The company is conducting Phase 3 clinical trials for the drug in chronic kidney disease and secondary hyperparathyroidism.
Paricalcitol is in Phase 3 clinical development. It is investigational and not yet approved, with completed Phase 3 trials in chronic kidney disease and secondary hyperparathyroidism.
Paricalcitol has completed Phase 3 trials including NCT00497146 (PRIMO study in CKD stage 3/4), NCT01020487 (pediatric CKD), NCT01341782 (Japanese hemodialysis patients), and NCT01382212 (pediatric end-stage renal disease).
Paricalcitol is also known by the brand name Zemplar. It is a vitamin D analog used for secondary hyperparathyroidism in chronic kidney disease, developed by AbbVie Inc.