NCT00469625

Brief Summary

Diabetic Nephropathy and other proteinuric renal diseases are the major cause of kidney disease in the United States. The degree of proteinuria is associated with risk for renal disease progression and cardiovascular outcomes. Deficiency of 1-25 Vitamin D develops early in CKD, and is undertreated. Vitamin D may have important effects on factors that drive proteinuria and renal disease progression in patients with proteinuric renal diseases. Therefore, Paricalcitol treatment may reduce proteinuria and slow renal deterioration.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

December 28, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

May 3, 2007

Last Update Submit

December 24, 2015

Conditions

Proteinuric Renal Disease

Interventions

paricalcitol (initial dose 1 mcg orally per day)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable chronic kidney disease
  • Urine protein : Creatinine ratio \> 0.4
  • Chronic kidney disease stage 2-4 with eGFR 15-90 ml/min
  • PTH (intact) \>20 pg/ml and \<250 pg/ml
  • Age 18-85
  • If on ACEI/ARB, then dose optimized (BP, K)

You may not qualify if:

  • Failure to provide informed consent
  • Glomerunephritis requiring active treatment with immunosuppresive therapy
  • Serum phosphorus \> 5.2
  • Serum calcium (adjusted for albumin)\> 10.0
  • Active malignancy
  • Likelihood of requiring renal replacement therapy within 1 year
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop Univ. Hospital

Mineola, New York, 11501, United States

Location

Related Publications (1)

  • Fishbane S, Chittineni H, Packman M, Dutka P, Ali N, Durie N. Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. Am J Kidney Dis. 2009 Oct;54(4):647-52. doi: 10.1053/j.ajkd.2009.04.036. Epub 2009 Jul 12.

    PMID: 19596163DERIVED

MeSH Terms

Interventions

paricalcitol
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 4, 2007

Study Start

July 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

December 28, 2015

Record last verified: 2015-12

Locations

US(1)