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Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

Primary Purpose

Chronic Kidney Disease, Kidney Transplantation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxercalciferol
placebo
25-OH Vitamin D3
Sponsored by
Mariana Markell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring kidney transplantation, kidney transplant recipients

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults of both genders between the ages of 18 and 65.
  • Kidney transplant at least 1 year prior to enrollment
  • Creatinine value of <2.5 mg/dl with no excursion >0.5 within the past 3 months
  • Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater
  • Hypovitaminosis D, as defined by a 25-OH Vitamin D value of <25 ng/ml
  • Intact PTH value between 150 and 600 pg/ml

Exclusion Criteria:

  • History of parathyroidectomy
  • History of prior intolerance to vitamin D therapy (not including hypercalcemia)
  • History of biopsy proven acute rejection over the 3 months preceding enrollment
  • Recent (over the past month) addition of an ACE inhibitor or Angiotensin -
  • Receptor Blocking agent - patients who have been on a stable dose are acceptable
  • Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable)
  • Postmenopausal woman or women receiving hormone replacement therapy

Sites / Locations

  • SUNY Downstate Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Doxercalciferol

Cholecalciferol

Arm Description

Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint.

Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint.

Outcomes

Primary Outcome Measures

- iPTH value of 100 pg/ml or lower
The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline.

Secondary Outcome Measures

Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels
The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study)
Change in FGF-23 levels
The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.
Change in serum bone turnover markers
The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months
Change in Protein/creatinine ratio
Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months) 6. Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months) The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months)

Full Information

First Posted
April 23, 2009
Last Updated
February 19, 2019
Sponsor
Mariana Markell
Collaborators
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00889629
Brief Title
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
Official Title
Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariana Markell
Collaborators
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.
Detailed Description
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. 25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D levels but it may not be enough to treat the parathyroid problems and bone disease. Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and parathyroid problems in dialysis patients but has not yet been studied in patients with kidney transplants. We are interested in seeing whether doxercalciferol given together with 25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone disease than 25-OH Vitamin D3 alone in patients with kidney transplants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Kidney Transplantation
Keywords
kidney transplantation, kidney transplant recipients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxercalciferol
Arm Type
Experimental
Arm Description
Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint.
Arm Title
Cholecalciferol
Arm Type
Placebo Comparator
Arm Description
Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint.
Intervention Type
Drug
Intervention Name(s)
Doxercalciferol
Other Intervention Name(s)
Hectorol (the other name for Doxercalciferol)
Intervention Description
Active group receives doxercalciferol (Hectorol) 1mcg
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Placebo for doxercalciferol
Intervention Description
Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
Intervention Type
Drug
Intervention Name(s)
25-OH Vitamin D3
Other Intervention Name(s)
(cholecalciferol)
Intervention Description
All groups received cholecalciferol
Primary Outcome Measure Information:
Title
- iPTH value of 100 pg/ml or lower
Description
The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels
Description
The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study)
Time Frame
6 months
Title
Change in FGF-23 levels
Description
The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.
Time Frame
6 months
Title
Change in serum bone turnover markers
Description
The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months
Time Frame
6 months
Title
Change in Protein/creatinine ratio
Description
Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months) 6. Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months) The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults of both genders between the ages of 18 and 65. Kidney transplant at least 1 year prior to enrollment Creatinine value of <2.5 mg/dl with no excursion >0.5 within the past 3 months Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater Hypovitaminosis D, as defined by a 25-OH Vitamin D value of <25 ng/ml Intact PTH value between 150 and 600 pg/ml Exclusion Criteria: History of parathyroidectomy History of prior intolerance to vitamin D therapy (not including hypercalcemia) History of biopsy proven acute rejection over the 3 months preceding enrollment Recent (over the past month) addition of an ACE inhibitor or Angiotensin - Receptor Blocking agent - patients who have been on a stable dose are acceptable Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable) Postmenopausal woman or women receiving hormone replacement therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Markell, MD
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

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