Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD

Daniel Coyne, Muralidhar Acharya, Ping Qiu, Hanna Abboud, Daniel Batlle, Steven Rosansky, Stephen Fadem, Barton Levine, Laura Williams, Dennis L. Andress, Stuart M. Sprague

Research output: Contribution to journalArticle

163 Citations (Scopus)

Abstract

• Background: The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 5. The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD. Methods: Three randomized, placebo-controlled, phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT. Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 (0.25 and 1.00 mL/s/1.73 m2), an average of 2 consecutive intact parathyroid hormone (iPTH) levels greater than 150 pg/mL (ng/L), 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL (2.00 and 2.50 mmol/L), and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less (≤1.68 mmol/L). Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks. Dosing was based on serum iPTH, calcium, and phosphorus levels. The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30% from baseline. Results: Two hundred twenty patients participated (n = 107, paricalcitol; n = 113, placebo). At least 2 consecutive decreases in iPTH levels of 30% or greater from baseline occurred in 91% of paricalcitol versus 13% of placebo patients (P < 0.001). Incidences of hypercalcemia, hyperphosphatemia, and elevated calcium-phosphorus product levels were not significantly different between groups. Similarly, no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo. Conclusion: Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels, phosphorus balance, and kidney function in patients with stages 3 and 4 CKD.

Original languageEnglish (US)
Pages (from-to)263-276
Number of pages14
JournalAmerican Journal of Kidney Diseases
Volume47
Issue number2
DOIs
StatePublished - Feb 2006
Externally publishedYes

Fingerprint

Secondary Hyperparathyroidism
Chronic Renal Insufficiency
Capsules
Parathyroid Hormone
Phosphorus
Calcium
Placebos
Therapeutics
Serum
Hyperphosphatemia
Kidney
Dosage Forms
Hypercalcemia
paricalcitol
Glomerular Filtration Rate
Safety
Injections
Incidence

Keywords

  • Active vitamin D
  • Calciuria
  • Hypercalcemia
  • Hyperphosphatemia

ASJC Scopus subject areas

  • Nephrology

Cite this

Coyne, D., Acharya, M., Qiu, P., Abboud, H., Batlle, D., Rosansky, S., ... Sprague, S. M. (2006). Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. American Journal of Kidney Diseases, 47(2), 263-276. https://doi.org/10.1053/j.ajkd.2005.10.007

Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. / Coyne, Daniel; Acharya, Muralidhar; Qiu, Ping; Abboud, Hanna; Batlle, Daniel; Rosansky, Steven; Fadem, Stephen; Levine, Barton; Williams, Laura; Andress, Dennis L.; Sprague, Stuart M.

In: American Journal of Kidney Diseases, Vol. 47, No. 2, 02.2006, p. 263-276.

Research output: Contribution to journalArticle

Coyne, D, Acharya, M, Qiu, P, Abboud, H, Batlle, D, Rosansky, S, Fadem, S, Levine, B, Williams, L, Andress, DL & Sprague, SM 2006, 'Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD', American Journal of Kidney Diseases, vol. 47, no. 2, pp. 263-276. https://doi.org/10.1053/j.ajkd.2005.10.007
Coyne, Daniel ; Acharya, Muralidhar ; Qiu, Ping ; Abboud, Hanna ; Batlle, Daniel ; Rosansky, Steven ; Fadem, Stephen ; Levine, Barton ; Williams, Laura ; Andress, Dennis L. ; Sprague, Stuart M. / Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD. In: American Journal of Kidney Diseases. 2006 ; Vol. 47, No. 2. pp. 263-276.
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abstract = "• Background: The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 5. The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD. Methods: Three randomized, placebo-controlled, phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT. Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 (0.25 and 1.00 mL/s/1.73 m2), an average of 2 consecutive intact parathyroid hormone (iPTH) levels greater than 150 pg/mL (ng/L), 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL (2.00 and 2.50 mmol/L), and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less (≤1.68 mmol/L). Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks. Dosing was based on serum iPTH, calcium, and phosphorus levels. The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30{\%} from baseline. Results: Two hundred twenty patients participated (n = 107, paricalcitol; n = 113, placebo). At least 2 consecutive decreases in iPTH levels of 30{\%} or greater from baseline occurred in 91{\%} of paricalcitol versus 13{\%} of placebo patients (P < 0.001). Incidences of hypercalcemia, hyperphosphatemia, and elevated calcium-phosphorus product levels were not significantly different between groups. Similarly, no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo. Conclusion: Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels, phosphorus balance, and kidney function in patients with stages 3 and 4 CKD.",
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AU - Batlle, Daniel

AU - Rosansky, Steven

AU - Fadem, Stephen

AU - Levine, Barton

AU - Williams, Laura

AU - Andress, Dennis L.

AU - Sprague, Stuart M.

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N2 - • Background: The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 5. The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD. Methods: Three randomized, placebo-controlled, phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT. Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 (0.25 and 1.00 mL/s/1.73 m2), an average of 2 consecutive intact parathyroid hormone (iPTH) levels greater than 150 pg/mL (ng/L), 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL (2.00 and 2.50 mmol/L), and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less (≤1.68 mmol/L). Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks. Dosing was based on serum iPTH, calcium, and phosphorus levels. The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30% from baseline. Results: Two hundred twenty patients participated (n = 107, paricalcitol; n = 113, placebo). At least 2 consecutive decreases in iPTH levels of 30% or greater from baseline occurred in 91% of paricalcitol versus 13% of placebo patients (P < 0.001). Incidences of hypercalcemia, hyperphosphatemia, and elevated calcium-phosphorus product levels were not significantly different between groups. Similarly, no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo. Conclusion: Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels, phosphorus balance, and kidney function in patients with stages 3 and 4 CKD.

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