Management of Mineral & Bone Disease in Hemodialysis-Calcitriol vs.

Status Terminated

Clinical Trial Summary

The purpose of this non-inferiority study is to compare the safety and effectiveness of a mineral and bone disease treatment protocol based on calcitriol to one based on paricalcitol in hemodialysis patients using revised Kidney Disease: Improving Global Outcomes (KDIGO) parathyroid hormone targets.

Clinical Trial Description

Active vitamin D analogs have been the mainstay of treatment for patients on hemodialysis with mineral and bone disease (MBD) for the past decade. Intravenous calcitriol is an active vitamin D analog which is nearly identical to natural 1, 25 Vitamin D3. Calcitriol results from the hydroxylation of previtamin D3 in the liver and kidney. Paricalcitol, 19-nor-1 , 25-dihydroxyvitamin D2, is a newer agent vitamin D analog. This agent is believed to have an effect more specific to the parathyroid gland, and less specific to absorption of calcium and phosphorus from the gut. Although both formulations appear equally effective in suppressing parathyroid hormone (PTH), studies have suggested a greater calcemic effect with intravenous calcitriol as compared to paricalcitol (1). Due to this, paricalcitol is the predominant active vitamin D analog used in hemodialysis patients in the United States. Two recent changes in the management of hemodialysis patients will likely reduce the amount of active vitamin D analogs used in the near future: the liberalization of PTH goals according to international guidelines, (2) and the implementation of bundled payments for dialysis by Medicare. These changes challenge previous studies that have analyzed the safety and efficacy of these medications. The purpose of this prospective, randomized, cross-over study will be to determine whether calcitriol is as safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients using the revised KDIGO parathyroid hormone targets. Our hypothesis is that calcitriol will be as equally safe and effective as paricalcitol in the treatment of MBD in hemodialysis patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01725113
Study type	Interventional
Source	Winthrop University Hospital
Contact
Status	Terminated
Phase	Phase 4
Start date	November 2012
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04510090` - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus	Phase 1
Completed	`NCT02546037` - Clotting With Different Dialyzer Membranes
Recruiting	`NCT02545920` - To Assess Ear Blood Flow During Dialysis
Completed	`NCT02134314` - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI	Phase 1/Phase 2
Recruiting	`NCT01912001` - Virtual Ward for Home Dialysis	N/A
Completed	`NCT01158742` - Live Kidney Donor Study -Renal Function Study	N/A
Completed	`NCT00986947` - Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates	Phase 2
Withdrawn	`NCT00807274` - Renal Function in Adults With Congenital Heart Disease.	N/A
Completed	`NCT00765661` - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients	Phase 2
Completed	`NCT00369382` - Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients	Phase 4
Completed	`NCT00183248` - Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients	Phase 1/Phase 2
Enrolling by invitation	`NCT05324878` - Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis
Completed	`NCT05272800` - BIS-guided Fluid Management in HD Patients	N/A
Completed	`NCT03836508` - Effect of Dialysis Membranes on Inflammatory and Immune Processes in Hemodialysis	N/A
Completed	`NCT01756508` - Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury	Phase 2
Completed	`NCT03723668` - Kidney Transplant Outcome and Organ Acceptance Practice Pattern: A Nationwide Analyses in the US and France
Recruiting	`NCT04277377` - Nanoparticle for DSA Removal
Terminated	`NCT00450333` - Dynepo Infrequent Dosing Study	Phase 3
Terminated	`NCT03840343` - Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease	Phase 1
Recruiting	`NCT04714853` - Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol — ECRIP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms