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NCT Number: NCT01163162

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

2 mcg oral Paricalcitol once per day for 7 days

Other names: Zemplar

Primary outcomes

  1. 24-hour Urine Creatinine Excretion Rate

    Time frame: 1 Week

    We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

Secondary outcomes

  1. Creatinine Clearance

    Time frame: 1 Week

    The primary outcome variable will be creatinine clearance. Subject will be used as random variable and maximal likelihood estimation methods will be used. We expect no differences between periods.

  2. Serum Creatinine

    Time frame: 1 Week

    We expect serum creatinine to confirm the results of creatinine clearance.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Abbott

Registry information

Acronym: Paricalcitol

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2010
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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