Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients

NCT00889629 | Completed Phase 4

• 1 other identifier: 08-080
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Kidney Transplantation

Keywords

kidney transplantation; kidney transplant recipients

Outcome Measures

Primary Outcomes (1)

• - 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.

  6 months

Secondary Outcomes (4)

• Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels

  6 months

• Change in FGF-23 levels

  6 months

• Change in serum bone turnover markers

  6 months

• Change in Protein/creatinine ratio

  6 months

Study Arms (2)

Doxercalciferol

EXPERIMENTAL

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.

Drug: Doxercalciferol; Drug: 25-OH Vitamin D3

Cholecalciferol

PLACEBO COMPARATOR

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.

Drug: placebo; Drug: 25-OH Vitamin D3

Interventions

Doxercalciferol DRUG

Active group receives doxercalciferol (Hectorol) 1mcg

Also known as: Hectorol (the other name for Doxercalciferol)

Doxercalciferol

placebo DRUG

Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)

Also known as: Placebo for doxercalciferol

Cholecalciferol

25-OH Vitamin D3 DRUG

All groups received cholecalciferol

Also known as: (cholecalciferol)

Cholecalciferol; Doxercalciferol

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mariana Markell: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11234, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

1 alpha-hydroxyergocalciferol; 19-nor-hexafluoride vitamin D3; Cholecalciferol

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mariana Markell, MD

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 29, 2009
• Study Start: November 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)