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

NCT01163162 | Completed Phase 4 Results

• 1 other identifier: 1003-15
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 24-hour Urine Creatinine Excretion Rate

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

  1 Week

Secondary Outcomes (2)

• Creatinine Clearance

  1 Week

• Serum Creatinine

  1 Week

Study Arms (1)

Paricalcitol

EXPERIMENTAL

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.

Drug: Paricalcitol

Interventions

Paricalcitol DRUG

2 mcg oral Paricalcitol once per day for 7 days

Also known as: Zemplar

Paricalcitol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Abbott: collaborator

Study Sites (1)

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Agarwal R, Hynson JE, Hecht TJ, Light RP, Sinha AD. Short-term vitamin D receptor activation increases serum creatinine due to increased production with no effect on the glomerular filtration rate. Kidney Int. 2011 Nov;80(10):1073-9. doi: 10.1038/ki.2011.207. Epub 2011 Jun 29.

  PMID: 21716260 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Rajiv Agarwal
• Organization: Indiana University

ragarwal@iu.edu

317 988 2241

Study Officials

• Rajiv Agarwal, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 21, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-04

Locations

US (1)