Anemia Clinical Trial - Paricalcitol Effect on Anemia in CKD

Status Completed

Clinical Trial Summary

Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.

Clinical Trial Description

To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01768351
Study type	Interventional
Source	Federico II University
Contact
Status	Completed
Phase	Phase 4
Start date	October 2010
Completion date	October 2012

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT00801931` - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders	Phase 1/Phase 2
Completed	`NCT02948283` - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia	Phase 1
Completed	`NCT03341338` - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed	`NCT00060398` - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer	Phase 3
Recruiting	`NCT05384691` - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions	Phase 2
Not yet recruiting	`NCT06309641` - Methemoglobinemia Following Intravenous Iron Treatment
Completed	`NCT03822884` - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers	Phase 1
Completed	`NCT02912494` - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT02930850` - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation	N/A
Completed	`NCT02912533` - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)	Phase 3
Completed	`NCT02384122` - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias	Phase 3
Completed	`NCT02603250` - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda	N/A
Completed	`NCT02176759` - Iron Absorption From Rice Fortified With Ferric Pyrophosphate	N/A
Completed	`NCT01922479` - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure	Phase 4
Completed	`NCT02310113` - Transfusion and Skeletal Muscle Tissue Oxygenation	N/A
Withdrawn	`NCT01934842` - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate	N/A
Completed	`NCT01693029` - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa	Phase 3
Completed	`NCT01458028` - Age and Gender Effects on the Pharmacokinetics of BAY85-3934	Phase 1
Completed	`NCT01432717` - Study of ACE-536 in Healthy Postmenopausal Women	Phase 1