Clinical Trials

Numerous clinical trials evaluate paricalcitol across Early Phase 1 through Phase 4 development stages, focusing primarily on secondary hyperparathyroidism, chronic kidney disease, end-stage renal disease, chronic pancreatitis, and pancreatic ductal adenocarcinoma. Sponsored by academic institutions, medical centers, and pharmaceutical organizations—including AbbVie, Abbott, Cedars-Sinai Medical Center, and the NIDDK—these studies encompass active recruiting, completed, and terminated protocols. Research includes evaluations of combination regimens in pancreatic cancer alongside assessments for chronic pancreatitis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05664880 ACTIVE_NOT_RECRUITING
Chronic Pancreatitis
Cedars-Sinai Medical Center
 2023-06-01 EARLY_PHASE1
NCT05365893 ACTIVE_NOT_RECRUITING
Pancreatic Ductal Adenocarcinoma
Fox Chase Cancer Center
 2021-10-20 EARLY_PHASE1
NCT06209268 NOT_YET_RECRUITING
Sepsis
University of Split, School of Medicine
 2025-05-01
NCT04064827 TERMINATED
Chronic Kidney Disease (CKD); Secondary Hyperparathyroidism (SHPT)
AbbVie
 2020-09-16 PHASE3
NCT03520790 TERMINATED
Pancreatic Cancer
Dana-Farber Cancer Institute
 2018-12-05 PHASE1
NCT03415854 COMPLETED
Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreas Metastases; Adenocarcinoma
HonorHealth Research Institute
 2018-01-31 PHASE2
NCT03138720 COMPLETED
Resectable Pancreatic Cancer; Unresectable Pancreatic Cancer; Pancreatic Adenocarcinoma; Neoadjuvant Pancreatic Cancer
HonorHealth Research Institute
 2017-05-23 PHASE2
NCT04524702 COMPLETED
Advanced Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8
Emory University
 2020-09-14 PHASE2
NCT05664880 Recruiting
Chronic Pancreatitis
Cedars-Sinai Medical Center|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2023-06-01 Early Phase 1
NCT02754726 COMPLETED
Untreated Metastatic Pancreatic Ductal Adenocarcinoma
HonorHealth Research Institute
 2016-04 PHASE2
NCT04994080 UNKNOWN
Secondary Hyperparathyroidism
Chengdu Suncadia Medicine Co., Ltd.
 2022-02-01 PHASE3
NCT02930902 COMPLETED
Resectable Pancreatic Carcinoma; Stage I Pancreatic Cancer AJCC v6 and v7; Stage IA Pancreatic Cancer AJCC v6 and v7; Stage IB Pancreatic Cancer AJCC v6 and v7; Stage II Pancreatic Cancer AJCC v6 and v7; Stage IIA Pancreatic Cancer AJCC v6 and v7; Stage IIB Pancreatic Cancer AJCC v6 and v7
M.D. Anderson Cancer Center
 2017-02-20 PHASE1
NCT04617067 COMPLETED
Advanced Pancreatic Cancer
Cancer Trials Ireland
 2020-10-16 PHASE2
NCT02876211 TERMINATED
Anemia
Hospital Son Espases
 2014-12 PHASE4
NCT03519308 TERMINATED
Pancreatic Cancer
Abramson Cancer Center at Penn Medicine
 2020-07-29 EARLY_PHASE1
NCT03883919 COMPLETED
Pancreatic Cancer; Pancreas Cancer; Cancer of the Pancreas
Washington University School of Medicine
 2019-07-11 PHASE1
NCT04054362 COMPLETED
Pancreatic Cancer
Barts & The London NHS Trust
 2018-11-29 PHASE2
NCT03300921 TERMINATED
Pancreatic Cancer
Abramson Cancer Center at Penn Medicine
 2017-09-28 PHASE1
NCT03331562 COMPLETED
Pancreatic Cancer; Pancreas Adenocarcinoma; Advanced Pancreatic Cancer; Metastatic Pancreatic Cancer; Metastatic Pancreatic Adenocarcinoma
Translational Genomics Research Institute
 2017-12-27 PHASE2
NCT03588884 COMPLETED
Secondary Hyperparathyroidism Due to Renal Causes; Vitamin D Insufficiency; CKD Stage 3; CKD Stage 4
OPKO Health, Inc.
 2018-06-08 PHASE4
NCT03415854 Completed
Pancreatic Cancer|Pancreatic Ductal Adenocarcinoma|Pancreatic Adenocarcinoma|Pancreas Metastases|Adenocarcinoma
HonorHealth Research Institute|Barts Cancer Institute|Abramson Cancer Center at Penn Medicine|Salk Institute for Biological Studies|Mayo Clinic|Princeton University|Imaging Endpoints|Translational Genomics Research Institute|Stand Up To Cancer|Cancer Research UK|Lustgarten Foundation|University of California San Diego
 2018-01-31 Phase 2
NCT03331562 Completed
Pancreatic Cancer|Pancreas Adenocarcinoma|Advanced Pancreatic Cancer|Metastatic Pancreatic Cancer|Metastatic Pancreatic Adenocarcinoma
Translational Genomics Research Institute|Stand Up To Cancer|Merck Sharp & Dohme LLC
 2017-12-27 Phase 2
NCT03023748 UNKNOWN
Endstage Renal Disease; Secondary Hyperparathyroidism
The University of Hong Kong
 2011-09 PHASE4
NCT01506947 COMPLETED
Moderate to Severe Secondary Hyperparathyroidism; Stage 5 Chronic Kidney Diseases
AbbVie (prior sponsor, Abbott)
 2012-05-10 PHASE4
NCT02686827 COMPLETED
Hypersensitivity
Laurian Jongejan
 2015-10 PHASE2
NCT02030860 COMPLETED
Adenocarcinoma of the Pancreas
Abramson Cancer Center at Penn Medicine
 2014-01 PHASE1
NCT02686827 Completed
Hypersensitivity
Laurian Jongejan|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2015-10 Phase 2
NCT01939977 COMPLETED
Secondary Hyperparathyroidism Due to Renal Causes
Fundación Senefro
 2014-01 PHASE4
NCT01138475 COMPLETED
Gastric Bypass; Parathyroid Hormone
Kerstyn C. Zalesin, M.D.
 2010-07 PHASE3
NCT01393808 COMPLETED
Type 2 Diabetes
Mario Negri Institute for Pharmacological Research
 2011-09 PHASE2
NCT02282813 COMPLETED
Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency
OPKO Health, Inc.
 2013-04 PHASE3
NCT01382212 COMPLETED
End-Stage Renal Disease; Secondary Hyperparathyroidism
AbbVie (prior sponsor, Abbott)
 2011-10 PHASE3
NCT01694160 COMPLETED
Proteinuria
Oslo University Hospital
 2013-01 PHASE3
NCT01436747 COMPLETED
Disorder of Transplanted Kidney; Proteinuria; Albuminuria
University Medical Centre Ljubljana
 2012-07 PHASE3
NCT01020487 COMPLETED
Chronic Kidney Disease Stage 3 and 4
AbbVie (prior sponsor, Abbott)
 2010-02 PHASE3
NCT01630408 WITHDRAWN
Heart Failure
Massachusetts General Hospital
 2014-03
NCT02090608 COMPLETED
Fabry Disease; Proteinuria
Federico II University
 2012-03
NCT01725113 TERMINATED
Kidney Failure; Secondary Hyperparathyroidism; Hyperphosphatemia; Hypercalcemia
Winthrop University Hospital
 2012-11 PHASE4
NCT00752102 COMPLETED
Chronic Kidney Disease; Vitamin D Deficiency; Coronary Calcification; Disorders of Calcium and Bone Metabolism
Joslin Diabetes Center
 2008-09 PHASE4
NCT01820767 COMPLETED
Chronic Kidney Disease
Ricardo Mouzo Mirco
 2012-08 PHASE3
NCT01820078 TERMINATED
Chronic Kidney Disease, Unspecified
Fundación Renal Iñigo Alvarez De Toledo
 2012-05 PHASE4
NCT00217477 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Roswell Park Cancer Institute
 2004-08 PHASE1
NCT00823303 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Washington University School of Medicine
 2009-02 PHASE4
NCT02372695 TERMINATED
Nephropathy
Effice Servicios Para la Investigacion S.L.
 2012-07 PHASE4
NCT00634582 TERMINATED
Metastatic Cancer; Prostate Cancer
Wake Forest University Health Sciences
 2009-01 PHASE2
NCT01792206 UNKNOWN
Type 2 Diabetes; Chronic Kidney Disease
Scott and White Hospital & Clinic
 2009-09
NCT01725113 Terminated
Kidney Failure|Secondary Hyperparathyroidism|Hyperphosphatemia|Hypercalcemia
Winthrop University Hospital
 2012-11 Phase 4
NCT01442272 UNKNOWN
Kidney Failure, Chronic; Disorder of Vitamin D
Hospital Universitario de Canarias
 2012-01 PHASE4
NCT01680198 COMPLETED
Chronic Kidney Disease.
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
 2011-06 PHASE3
NCT00417612 COMPLETED
Hypophosphatemia, Familial; Hyperparathyroidism
Yale University
 2007-01 PHASE3
NCT01197664 TERMINATED
Mucinous Adenocarcinoma of the Rectum; Stage IIA Rectal Cancer; Stage IIB Rectal Cancer; Stage IIC Rectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Rectal Cancer
Wake Forest University Health Sciences
 2010-08 PHASE1
NCT01220050 COMPLETED
Renal Transplant; Secondary Hyperparathyroidism
Mario Negri Institute for Pharmacological Research
 2009-09 PHASE2
NCT01331317 COMPLETED
Cardiovascular Disease; Diabetic Nephropathy
Peter Rossing
 2010-04 PHASE4
NCT01341782 COMPLETED
Secondary Hyperparathyroidism; Hemodialysis
AbbVie (prior sponsor, Abbott)
 2011-05 PHASE3
NCT01136564 COMPLETED
Chronic Kidney Disease
Erling Bjerregaard Pedersen
 2010-07 PHASE2
NCT00587158 COMPLETED
Transplant; Failure, Kidney; Renal Disease, End Stage; Hyperparathyroidism, Secondary
Mayo Clinic
 2007-01
NCT00637897 COMPLETED
Breast Cancer
Wake Forest University Health Sciences
 2008-03 PHASE1
NCT01003275 COMPLETED
Chronic Kidney Disease
University of Washington
 2009-10 PHASE2
NCT00796679 COMPLETED
Chronic Kidney Disease
The University of Hong Kong
 2008-10
NCT01012414 TERMINATED
Coronary Artery Disease; Chronic Kidney Disease; Hypovitaminosis D; Secondary Hyperparathyroidism
Thomas Jefferson University
 2010-01 PHASE3
NCT00977080 COMPLETED
Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis
Abbott
 2009-11 PHASE4
NCT01768351 COMPLETED
Anemia; Chronic Kidney Disease
Federico II University
 2010-10 PHASE4
NCT00915876 COMPLETED
Chronic Kidney Disease
Amy Barton Pai
 2009-03
NCT01163162 COMPLETED
Chronic Kidney Disease
Indiana University
 2010-08 PHASE4
NCT00958451 COMPLETED
Secondary Hyperparathyroidism; Chronic Kidney Disease
Salem Veterans Affairs Medical Center
 2009-07 PHASE4
NCT02011828 COMPLETED
Inflammation; Insulin Resistance
University of Utah
 2009-05 PHASE1
NCT02322632 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2010-11 PHASE1
NCT01071070 COMPLETED
Chronic Kidney Disease
Abbott
 2009-11 PHASE3
NCT00497146 COMPLETED
Chronic Kidney Disease; Left Ventricular Hypertrophy
AbbVie (prior sponsor, Abbott)
 2008-02 PHASE3
NCT00469599 TERMINATED
Secondary Hyperparathyroidism; Chronic Kidney Disease; Vitamin D Deficiency
Zealand University Hospital
 2007-07
NCT00891813 COMPLETED
Secondary Hyperparathyroidism; Renal Insufficiency, Chronic; Parathyroid Hormone; Hemodialysis; Hypercalcemia
Abbott
 2009-05 PHASE4
NCT00537979 COMPLETED
Secondary Hyperparathyroidism; Dialysis
Abbott
 2007-09 PHASE4
NCT00990704 COMPLETED
Secondary Hyperparathyroidism; Hemodialysis
Abbott
 2009-10 PHASE2
NCT01265615 COMPLETED
Cardiorenal Syndrome; Chronic Allograft Nephropathy
Ural State Medical University
 2009-10 PHASE4
NCT00656032 COMPLETED
End Stage Renal Disease
Vanderbilt University
 2008-04 PHASE2
NCT00701805 COMPLETED
Secondary Hyperparathyroidism; Hemodialysis
Abbott
 2008-07 PHASE2
NCT00599963 WITHDRAWN
IgA Nephropathy
Chinese University of Hong Kong
 2008-01 PHASE3
NCT00800358 COMPLETED
Hyperparathyroidism; Kidney Disease
Penang Hospital, Malaysia
 2008-11
NCT00421733 COMPLETED
Diabetic Nephropathy; Chronic Kidney Disease
Abbott
 2006-12 PHASE2
NCT00664430 TERMINATED
Secondary Hyperparathyroidism; Dialysis
Abbott
 2009-01 PHASE4
NCT00616902 TERMINATED
Chronic Kidney Disease (CKD) Stage 5; Hypertrophy, Left Ventricular
Abbott
 2009-01 PHASE3
NCT00258258 TERMINATED
Multiple Myeloma and Plasma Cell Neoplasm
Roswell Park Cancer Institute
 2005-08 PHASE1
NCT00667576 COMPLETED
Chronic Kidney Disease on Hemodialysis; Secondary Hyperparathyroidism
Abbott
 2008-04 PHASE2
NCT00469625 WITHDRAWN
Proteinuric Renal Disease
Winthrop University Hospital
 2006-07
NCT00294866 COMPLETED
Kidney Failure
Fresenius Medical Care North America
 2006-03 PHASE4
NCT00686751 COMPLETED
End Stage Renal Disease; Hemodialysis; Inflammatory Response; Cardiovascular Disease
Renal Research Institute
 2004-12 PHASE2
NCT00428246 COMPLETED
Chronic Kidney Disease; Endothelial Dysfunction; Inflammation; Hypertension
Indiana University
 2006-11
NCT00646932 COMPLETED
Chronic Kidney Disease
Abbott
 2005-11 PHASE2
NCT00064376 COMPLETED
Leukemia; Myelodysplastic Syndromes
Cedars-Sinai Medical Center
 2003-05 PHASE2
NCT00646035 COMPLETED
End Stage Renal Disease
Abbott
 2002-01 PHASE3
NCT00307840 COMPLETED
Secondary Hyperparathyroidism
Papageorgiou General Hospital
 2005-02 PHASE4
NCT00062699 TERMINATED
End-Stage Kidney Disease
Abbott
 2003-04 PHASE4
NCT00048516 COMPLETED
Renal Insufficiency, Chronic
Abbott
 2002-02 PHASE3
NCT00053547 COMPLETED
Secondary Hyperparathyroidism; End Stage Renal Disease
Abbott
 2002-01 PHASE4
NCT00053378 COMPLETED
Hypocalcemia
Abbott
 2002-01 PHASE2
NCT00454350 COMPLETED
Secondary Hyperparathyroidism
Genzyme, a Sanofi Company
 2007-02 PHASE4
NCT00048438 COMPLETED
Renal Insufficiency, Chronic
Abbott
 2002-02 PHASE3
NCT00048451 COMPLETED
Renal Insufficiency, Chronic
Abbott
 2002-02 PHASE3
NCT00463021 COMPLETED
Secondary Hyperparathyroidism
Genzyme, a Sanofi Company
 2007-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the Paricalcitol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paricalcitol acts as a selective agonist of the vitamin D receptor, binding the target to downregulate parathyroid hormone mRNA transcription and suppress parathyroid cell proliferation. By inhibiting excessive hormone synthesis and parathyroid cellular expansion, paricalcitol provides targeted clinical efficacy in managing secondary hyperparathyroidism associated with chronic kidney disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.