Phase 4
Completed N=16
The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Source: ClinicalTrials.gov NCT01163162 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: 24-hour Urine Creatinine Excretion Rate — 17.6 mg/24hour/day
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Urine Creatinine Excretion Rate |
17.6 | — |
| SECONDARY Creatinine Clearance |
0.49 | — |
| SECONDARY Serum Creatinine |
0.010 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01163162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.