THERAPY DOSSIER · th-a32f7ce565cb

Paricalcitol, a vitamin D receptor agonist

Hormone · Vitamin D receptor agonist (AGONIST, direct interaction, disease efficacy)

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Evidence & regulatory context

Mechanism: Vitamin D receptor agonist (AGONIST, direct interaction, disease efficacy)
Target: CHEMBL1977
Injury models: Chemical/toxin · Endotoxin/LPS
Reported indication: Not recorded
First approval: 1998
Development stage: Not recorded
ChEMBL record: CHEMBL1200622 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Paricalcitol; Zemplar; Compound 49510
Note: Not recorded

Clinical trials 9

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT00294866 ↗PHASE4completed

An Open Label, Multi-Center Study of the Effect of Paricalcitol on Markers of Inflammation in Patients With Stage 5 Chronic Kidney Disease on Hemodialysis

Kidney Failure

Enrolment: 64 · Results not recorded

NCT00463021 ↗PHASE4completed

A Phase 4 Study to Determine Clinically Appropriate Doses of Hectorol When Converting From Zemplar (Paricalcitol Injection) in Stage 5 CKD Subjects on Hemodialysis

Secondary Hyperparathyroidism

Enrolment: 36 · Results not recorded

NCT01725113 ↗PHASE4terminated

A Randomized, Prospective, Cross-Over Study of Calcitriol vs. Paricalcitol in the Treatment of Mineral and Bone Disease in Hemodialysis Patients

Kidney Failure · Secondary Hyperparathyroidism · Hyperphosphatemia · Hypercalcemia

Enrolment: 16 · Results not recorded

NCT00307840 ↗PHASE4completed

Initial Dosing of Paricalcitol Based on iPTH Parathyroid Hormone Levels in Hemodialysis Patients With Secondary Hyperparathyroidism

Secondary Hyperparathyroidism

Enrolment not recorded · Results not recorded

NCT01436747 ↗PHASE3completed

Efficacy and Safety of Selective Vitamin D Receptor Activation With Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients

Disorder of Transplanted Kidney · Proteinuria · Albuminuria

Enrolment: 168 · Results not recorded

NCT00646035 ↗PHASE3completed

A Phase III Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

End Stage Renal Disease

Enrolment: 75 · Results not recorded

NCT01792206 ↗NAunknown

Effect of Paricalcitol (Zemplar) on Endothelial Function and Inflammation in Type 2 Diabetes and Chronic Kidney Disease

Type 2 Diabetes · Chronic Kidney Disease

Enrolment: 60 · Results not recorded

NCT01083849 ↗Phase not recordedcompleted

Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

Kidney Insufficiency · Secondary Hyperparathyroidism

Enrolment: 761 · Results not recorded

NCT01368042 ↗Phase not recordedcompleted

Quality of Life in Greek Hemodialysis Patients Receiving Zemplar i.v. (QualitiZe)

Chronic Kidney Disease · Secondary Hyperparathyroidism

Enrolment: 265 · Results not recorded

Preclinical evidence 2

2 studies reported at therapy level; 2 evidence entries itemised.

PMID 33259938 ↗2020Reported benefit

Vitamin D/VDR attenuate cisplatin-induced AKI by down-regulating NLRP3/Caspase-1/GSDMD pyroptosis pathway.

MouseChemical/toxinWild type, VDR knockout and renal tubular cell specific VDR overexpressing mice; background strain not statedHigh dose in wild type mice and low dose in tubular VDR ove…Pretreatment before cisplatin administration

Model: Cisplatin induced acute kidney injury in mice, with parallel in vitro cisplatin injury in human tubular epithelial (HK-2) cells

In wild type mice, high dose paricalcitol pretreatment alleviated cisplatin induced loss of renal function, tissue injury and cell death, upregulated VDR and reduced NLRP3, GSDMD-N, cleaved caspase-1 and mature IL-1 beta. VDR knockout mice showed more severe renal injury and greater pyroptosis prot…

Extraction: extract · Supplied extraction confidence: 0.55. Machine-extracted fields require source verification.

PMID 26675943 ↗2015Reported benefit

Vitamin D/VDR signaling attenuates lipopolysaccharide-induced acute lung injury by maintaining the integrity of the pulmonary epithelial barrier.

MouseEndotoxin/LPSC57BL/6J background, vitamin D receptor wild-type and knockoutMale and femalen = Two mice per sex per treatment group, that is about n = 4 p…Intraperitoneal0.5 ug/kg body weight in propylene glycol:ethanol 90:1030 min before LPS instillation

Model: Lipopolysaccharide-induced acute lung injury, Escherichia coli 0111:B4 LPS 10 mg/kg intratracheally, assessed 12 h later

Paricalcitol pretreatment reduced lung injury score, oedema, BALF protein and proinflammatory cytokine induction, and preserved occludin and ZO-1 expression, whereas VDR knockout mice showed more severe LPS-induced injury.

Extraction: extract · Supplied extraction confidence: 0.8. Machine-extracted fields require source verification.

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