Metabolic Effects of Paricalcitol

NCT ID: NCT01003275

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-11-30

Brief Summary

The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).

Detailed Description

Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.

This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Paricalcitol followed by placebo

Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Paricalcitol

Intervention Type: DRUG

Two 1 mcg soft gels by mouth daily for 8 weeks

Placebo

Intervention Type: DRUG

Two soft gels by mouth daily for 8 weeks

Placebo followed by paricalcitol

Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Paricalcitol

Intervention Type: DRUG

Two 1 mcg soft gels by mouth daily for 8 weeks

Placebo

Intervention Type: DRUG

Two soft gels by mouth daily for 8 weeks

Interventions

Paricalcitol

Two 1 mcg soft gels by mouth daily for 8 weeks

Intervention Type: DRUG

Placebo

Two soft gels by mouth daily for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Zemplar

Eligibility Criteria

Inclusion Criteria

• Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
• Fasting glucose 100-125 mg/dL
• 18 years and older

Exclusion Criteria

• Diagnosed with diabetes mellitus
• Use of diabetes medications (insulin or oral hypoglycemics)
• Prior dialysis or transplantation
• Planning to leave the area within 6 months
• Participation in another clinical trial within 30 days
• Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
• Serum calcium more than 10.2 mg/dL
• Pregnancy or breast-feeding
• Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
• Incontinent of urine
• Cancer (other than skin cancer) within 5 years
• Tuberculosis
• Sarcoidosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ian deBoer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian H de Boer, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22.

Reference Type: RESULT

PMID: 22913981 (View on PubMed)

Other Identifiers

35501-D

Identifier Type: -

Identifier Source: org_study_id