The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

Indiana University

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: Paricalcitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01163162

1003-15

Details and patient eligibility

About

The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Stage 3 or 4 CKD
• Ability to give informed consent

Exclusion criteria

• Serum Calcium > 10 g/dL
• Serum Phosphorous > 6 g/dL
• On > 400 units/d Vitamin D therapy
• Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion
• On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)
• Allergic to radiocontrast dye

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Paricalcitol

Experimental group

Description:

After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.

Treatment:

Drug: Paricalcitol