paricalcitol / Generic mfg. - LARVOL DELTA

Dose response of PTH and FGF23 to paricalcitol in patients with end-stage renal failure on chronic intermittent hemodialysis. (PubMed, Clin Nephrol) - P3 | "Treatment with paricalcitol resulted in a significant reduction in PTH levels at both 6 and 12 weeks compared to placebo. The suppression of PTH levels with paricalcitol was possible without elevating FGF23 within the restrictions of this short duration study, at least if over-suppression of PTH is avoided by dose adaption. Our findings suggest a cautious lower oral paricalcitol starting dose to mitigate the initial spike in FGF23 while effectively managing PTH levels."

Clinical • Journal • Chronic Kidney Disease • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism • FGF23

ROS-responsive graphene-hyaluronic acid nanomedicine for targeted therapy in renal ischemia/reperfusion injury. (PubMed, Theranostics) - "P/HA/rGO selectively accumulated in IR-injured kidneys via HA-CD44 interactions, decreased serum NGAL and cystatin C levels, and effectively attenuated tubular injury, fibrosis, inflammation, and apoptosis compared to vehicle-treated controls. The P/HA/rGO nanoplatform enables kidney-targeted delivery of paricalcitol with ROS-scavenging and ROS-responsive release properties, providing a promising therapeutic strategy to suppress the AKI-to-CKD transition via integrated targeting and microenvironment-responsive therapy."

Journal • Acute Kidney Injury • Cardiovascular • Chronic Kidney Disease • Fibrosis • Immunology • Inflammation • Nephrology • Renal Disease • Reperfusion Injury • CST3

Discovery Potential Hub Genes and Pathways in Keloid Fibroblast Development Based on Bioinformatics Analysis. (PubMed, Int J Genomics) - "Paricalcitol and phosphine were identified as potential therapeutic candidates. This study identified three hub genes-BMP4, POSTN, and WNT5A-that are closely linked to keloid fibroblast hyperplasia and may serve as potential biomarkers for inhibiting keloid fibroblast hyperplasia. Further molecular and animal studies are needed to fully understand the mechanisms of keloid development."

Journal • Dermatology • Fibrosis • Pain • Pruritus • BMP4 • HIF1A • POSTN • SMAD3 • SPP1

PINBALL: Paricalcitol Addition to Chemotherapy in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P2 | N=27 | Completed | Sponsor: Barts & The London NHS Trust | Active, not recruiting ➔ Completed | N=14 ➔ 27 | Trial completion date: Jun 2025 ➔ Feb 2025

Enrollment change • Trial completion • Trial completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

ALLIANCE: A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Cedars-Sinai Medical Center | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial primary completion date • Pancreatitis

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=2 | Terminated | Sponsor: AbbVie | N=16 ➔ 2 | Trial completion date: Mar 2027 ➔ May 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Nov 2026 ➔ May 2025; Company Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism

Long-Term Efficacy of Etelcalcetide in a Patient on Hemodialysis with Refractory Secondary Hyperparathyroidism: A 15-Month Follow-Up Case Report (KIDNEY WEEK 2025) - "Persistent SHPT (baseline iPTH 200–500 pg/mL) proved resistant to sequential therapies: paricalcitol (5 μg biweekly, halted for hypercalcemia and hyperphosphatemia) and cinacalcet (25–50 mg daily, discontinued for severe dyspepsia). Dynamic monitoring of calcium and iPTH is crucial for maintaining therapeutic stability. Changes in serum levels of parathyroid hormone (PTH), calcium (Ca), and phosphorus (P)"

Case report • Clinical • Dyspepsia • Endocrine Disorders • Metabolic Disorders • Nephrology • Secondary Hyperparathyroidism • Vasculitis

Refractory Hungry Bone Syndrome in ESKD Following Parathyroidectomy (KIDNEY WEEK 2025) - "She was hospitalized for 19 days with persistent hypocalcemia and hypophosphatemia requiring a calcium drip, elemental calcium, calcitriol, paricalcitol with dialysis, oral phosphate, and high calcium (3 Ca++) dialysate bath...It emphasizes calcium repletion to avoid mealtime and phosphorus to prevent chelation and poor absorption. Finally, rapid symptom resolution can be achieved in patients on hemodialysis by utilizing a high calcium dialysate bath."

Endocrine Disorders • Immunology • Inflammatory Arthritis • Lupus • Musculoskeletal Pain • Osteoporosis • Renal Disease • Rheumatology • Secondary Hyperparathyroidism

Clinical Outcomes and Consumption in Extended Hemodialysis and Online Hemodiafiltration: Multicenter Analysis (KIDNEY WEEK 2025) - "Demographic, clinical, and laboratory variables (at baseline, 6 and 12 months), emergency hospitalizations, and annual consumption of dialysis medications (sodium heparin, erythropoiesis-stimulating agents [ESA], iron, paricalcitol, etecalcetide) were collected...In our experience, HDx and HDF-OL showed comparable efficacy in median solute clearance and analytical parameters with no differences in urgent hospitalization events. HDx may offer additional advantages, such as reduced consumption of certain drugs and potential water savings compared to HDF-OL."

Clinical • Clinical data • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • B2M

Efficacy of Paricalcitol in the Management of CKD-MBD in Patients on Intermittent In-Center Hemodialysis: A 52-Week Follow-Up Study (KIDNEY WEEK 2025) - "Conclusion Paricalcitol demonstrated efficacy in achieving target CKD-MBD goals, reducing pill burden, and improving EPO responsiveness in ICHD patients over 52 weeks. These findings underscore the need for large-scale prospective trials to validate its long-term benefits and optimize CKD-MBD management strategies in dialysis-dependent populations."

Clinical • Cardiovascular • Chronic Kidney Disease • Inflammation • Nephrology • Renal Disease

Vitamin D receptor modulates autophagy via miR-20a-5p/ATG16L1 axis to alleviate lipopolysaccharide-induced acute kidney injury. (PubMed, Ren Fail) - "Through establishment of S-AKI models in VDR knockout mice and treatment with vitamin D receptor agonist paricalcitol, we reported that VDR deficiency exacerbated renal functional deterioration and histological alterations induced by lipopolysaccharide, whereas VDR activation markedly ameliorated these impairments...Moreover, luciferase and ChIP experiments corroborated the direct transcriptional regulation role of VDR on miR-20a-5p. Collectively, this investigation illuminates a novel pathway through which VDR regulate autophagic dysfunction induced by lipopolysaccharide via the VDR-miR20a-5p-ATG16L1 axis, thereby introducing a promising therapeutic target against sS-AKI."

Journal • Acute Kidney Injury • Diabetic Nephropathy • Infectious Disease • Nephrology • Renal Disease • Septic Shock • ATG16L1 • MIR20A • VDR

Paricalcitol-mediated vitamin D receptor activation attenuates neuronal ferroptosis via cAMP-PKA-DRP1 signaling pathway after intracerebral hemorrhage. (PubMed, Neurotherapeutics) - "Critically, its sufficiency was demonstrated as direct activation of the pathway with an agonist mimicked PAL's anti-ferroptotic effects. Collectively, these findings reveal that VDR activation by paricalcitol ameliorates neuronal injury after ICH by directly inhibiting ferroptosis through the cAMP-PKA-DRP1-mediated preservation of mitochondrial integrity, highlighting a potent therapeutic strategy."

Journal • Cerebral Hemorrhage • Hematological Disorders

Attenuating amiodarone-induced lung toxicity by the vitamin D receptor activator paricalcitol in rats: targeting TLR4/NF-κB/HIF-1α and TGF-β/Smad signaling pathways. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Interestingly, these results were accompanied by suppressed hypoxia-inducible factor-1α (HIF-1α) lung expression. Taken together, paricalcitol protected against amiodarone-induced lung damage in rats through antioxidant, anti-inflammatory, and antifibrotic activities."

IO biomarker • Journal • Preclinical • Fibrosis • Immunology • Oncology • Pulmonary Disease • Respiratory Diseases • HIF1A • SMAD4 • TGFB1 • TLR4 • TNFA • VDR

Paricalcitol and hydroxychloroquine modulates extracellular matrix and enhance chemotherapy efficacy in pancreatic cancer. (PubMed, Cancer Gene Ther) - "In a previous publication, our group defined some of the mechanisms that vitamin D analogue paricalcitol (P) and hydroxychloroquine (H) potentiated the effects of gemcitabine-based chemotherapy in PDAC. Based on this, we hypothesized that PH may potentiate 5-fluorouracil (5FU) and Oxaliplatin-based chemotherapy, and this may involve a novel mechanism of extracellular matrix (ECM) modulation...We identified a new mechanism of action of PH through inhibiting ITGB4, leading to ECM modulation. These results suggest that the combination of PH with cytotoxic chemotherapy should be tested in PDAC clinical trials."

Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • ITGB4

KDM6B enhances anti-PD-L1 immunotherapy efficacy by increasing CD8+ T-cell infiltration in colorectal cancer. (PubMed, J Cancer) - " KDM6B potentially suppresses CRC progression by enhancing CD8+ T cell infiltration via dual mechanisms: STAT3-mediated transcriptional activation and H3K27me3 demethylase-dependent epigenetic remodeling of PD-L1 and chemokine genes (CCL5/CXCL9/CXCL10). The synergistic effect of KDM6B inducer paricalcitol with anti-PD-L1 enhances antitumor immunity, supporting its potential combination strategy for CRC treatment."

IO biomarker • Journal • Colorectal Cancer • Oncology • Solid Tumor • CD8 • CXCL1 • CXCL10 • CXCL9 • KDM6B

Severe consequences of uncontrolled tertiary hyperparathyroidism in a limited resources setting: a case report. (PubMed, Front Nephrol) - "Despite initial management with medications such as paricalcitol and alfacalcidol, the lack of access to appropriate therapies and the postponement of a planned parathyroidectomy worsened her condition. This case highlights the importance of early diagnosis and timely intervention, particularly in resource-limited settings, emphasizing the urgent need for kidney transplant programs and improved preventive strategies in developing countries."

Journal • Chronic Kidney Disease • Endocrine Disorders • Gynecology • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease • Secondary Hyperparathyroidism • Transplantation

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=16 | Active, not recruiting | Sponsor: AbbVie | Suspended ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=16 | Suspended | Sponsor: AbbVie | Recruiting ➔ Suspended

Trial suspension • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism

A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (clinicaltrials.gov) - P3 | N=16 | Recruiting | Sponsor: AbbVie | Trial completion date: Oct 2026 ➔ Mar 2027 | Trial primary completion date: Jun 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Pediatrics • Renal Disease • Secondary Hyperparathyroidism

Clinical value of serum iPTH, ALP and serum markers levels in patients with secondary hyperparathyroidism receiving paricalcitol combined with cinacalcet. (PubMed, J Med Biochem) - "The combination of paricalcitol and cinacalcet was effective in reducing iPTH, calcium, phosphorus, and ALP and improving Hb and Alb levels in patients with secondary hyperparathyroidism on maintenance hemodialysis. This treatment approach offers significant benefits in managing SHPT."

Journal • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

A high-fat diet suppresses growth hormone synthesis and secretion by influencing the Vit D receptor and Pit1. (PubMed, Endocrine) - "HFD induced lipid deposition in the pituitary may cause GH deficiency, and VDR - Pit1 may be at least partially involved in the process."

Journal • Diabetes • Endocrine Disorders • Genetic Disorders • Growth Hormone Deficiency • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • VDR

NSUN2-mediated m5C modification of KDM6B mRNA enhances osteoclast differentiation and promotes breast cancer bone metastasis. (PubMed, Cancer Lett) - "Strikingly, activating KDM6B expression with paricalcitol or inhibiting the Notch pathway with DAPT effectively counteracted NSUN2-induced osteolytic bone metastasis in vivo. Collectively, our findings underscore the pivotal role of the NSUN2-KDM6B-Notch axis in promoting osteoclast differentiation and bone metastasis in BCa, providing potential therapeutic targets for BCa patients with bone metastasis."

Journal • Breast Cancer • Oncology • Solid Tumor • KDM6B • NICD • NOTCH1 • NSUN2 • PPIA • TNFSF11

Real-world data from a national survey on management of CKD-associated osteoporosis among Italian nephrologists. (PubMed, Arch Osteoporos) - "The availability of bone biomarkers is heterogeneous, and an uncertainty still exists regarding the clinical use of biomarkers in CKD-associated osteoporosis. Nonetheless, our findings indicate that Italian nephrologists are increasingly taking proactive steps to prevent and treat bone fragility in CKD patients."

Biomarker • Journal • Real-world evidence • Cardiovascular • Chronic Kidney Disease • Musculoskeletal Diseases • Nephrology • Orthopedics • Osteoporosis • Renal Disease • Rheumatology • FGF23 • MGP • TRAP

Pre-operative Treatment for Patients With Untreated Pancreatic Cancer (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: HonorHealth Research Institute | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CA 19-9

Annual Aortic Valve Velocity as a Predictor of Systemic Calcification and Mortality: A Novel Monitoring Approach in Dialysis (ERA 2025) - " The baseline demographics, laboratory, and clinical characteristics, including daily elemental calcium and calcitriol or paricalcitol usage, were similar between Vmax-stable and Vmax-increased groups... During a follow-up of 24 years, increasing Vmax values were associated with longitudinally higher CaxP levels and mortality in dialysis patients. Even if the increase is subclinical, Vmax follow-up is a non-invasive, easily accessible method and might identify the high-risk group regarding cardiovascular mortality in the dialysis population."

Cardiovascular • Nephrology • Renal Disease