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Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Paricalcitol
Ergocalciferol
Sponsored by
Salem Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Calcium, Vitamin D deficiency, Chronic Kidney disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female chronic kidney disease patients at least 18 years of age.
  2. Patients should be able and willing to provide written informed consent and HIPAA Authorization.
  3. Chronic kidney disease stage 3 or 4.
  4. Plasma intactPTH level above 75pg/ml.
  5. Serum 25 OHD level below 30ng/ml.
  6. Negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy.
  7. Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior to screening.

Exclusion Criteria:

  1. Women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control.
  2. Patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study.
  3. Major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery).
  4. Patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years.
  5. Patients with a medical status that the PI decides would preclude participation.
  6. Patients on hemodialysis or peritoneal dialysis.
  7. Patients with a functional renal transplant.
  8. Patients with allergies to study drugs.
  9. Patients with acute renal failure with the past 12 weeks.
  10. Patients with clinically significant gastrointestinal or liver disease.
  11. Patients with active granulomatous disease.
  12. Patients with urine calcium:creatinine ratio of more than 0.2.
  13. Patients who received vitamin D analogs, calcimimetics, or biphosphonates within 4 weeks before screening. Treatment with any one of these medicines during the study is not permitted.

Sites / Locations

  • VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Paricalcitol

Ergocalciferol

Arm Description

Arm 1: 40 patients will be assigned to paricalcitol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.

Arm 2: 40 patients will be assigned to the Ergocalciferol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.

Outcomes

Primary Outcome Measures

To achieve 2 consecutive iPTH measurements with 30% or greater decrease from baseline

Secondary Outcome Measures

To achieve 25OHD level above 30 ng/ml and change cardiovascular markers

Full Information

First Posted
August 11, 2009
Last Updated
March 23, 2011
Sponsor
Salem Veterans Affairs Medical Center
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00958451
Brief Title
Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients
Official Title
Response of Secondary Hyperparathyroidism to Paricalcitol Versus Ergocalciferol in Patients With Stage 3 and 4 Chronic Kidney Disease With Vitamin D Deficiency: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Salem Veterans Affairs Medical Center
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin D replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (PTH) levels in patients with stage 3 and 4 CKD and vitamin D deficiency or insufficiency. The purpose of this study is to determine which of these two approaches is more successful.
Detailed Description
This study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin D levels as defined by K DOQI Guidelines. Patients will be randomized to receive oral daily ergocalciferol or paricalcitol. A total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. Outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. Baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords
Calcium, Vitamin D deficiency, Chronic Kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Active Comparator
Arm Description
Arm 1: 40 patients will be assigned to paricalcitol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.
Arm Title
Ergocalciferol
Arm Type
Active Comparator
Arm Description
Arm 2: 40 patients will be assigned to the Ergocalciferol treatment group. Patients will be randomized once they meet inclusion and exclusion criteria. If patients are not on any vitamin D treatment when enrolled, they will have 2 screening visits before randomization. Screening visits will consist of a physical exam and lab tests to measure Vitamin D, calcium, iPTH, and safety profile. Patients on vitamin D treatment prior to study will have a minimum 4 week washout period before screening tests. Patients' Lean Body Mass and Aortic Blood Pressure and pulse wave velocity will be measured before dosing. Cardiovascular markers will be checked throughout the study. Patients will be monitored monthly after starting study treatment. Total treatment period: 4 months.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Intervention Description
Patients will receive 1mcg once daily orally if iPTH is less than 500pg/ml; Patients will receive 2mcg once daily orally if iPTH is more than 500pg/ml. Duration of administration will be 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Intervention Description
If baseline 25 OHD level is less than 5ng/mml: ergocalciferol 50,000 units once a week orally for 12 weeks, then 50,000 units monthly for total duration of 16 weeks. If baseline 25 OHD is between 5 and 15mg/ml: Ergocalciferol 50,000 units once a week orally for 4 weeks, then 50,000 units once a month for total duration of 16 weeks. If baseline 25 OHD level is between 16 and 30ng/ml: Ergocalciferol 50,000 units orally once every 4 weeks for 16 weeks.
Primary Outcome Measure Information:
Title
To achieve 2 consecutive iPTH measurements with 30% or greater decrease from baseline
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To achieve 25OHD level above 30 ng/ml and change cardiovascular markers
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female chronic kidney disease patients at least 18 years of age. Patients should be able and willing to provide written informed consent and HIPAA Authorization. Chronic kidney disease stage 3 or 4. Plasma intactPTH level above 75pg/ml. Serum 25 OHD level below 30ng/ml. Negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy. Patients need to be off of any Vitamin analogues or preparations for 4 weeks prior to screening. Exclusion Criteria: Women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control. Patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study. Major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery). Patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years. Patients with a medical status that the PI decides would preclude participation. Patients on hemodialysis or peritoneal dialysis. Patients with a functional renal transplant. Patients with allergies to study drugs. Patients with acute renal failure with the past 12 weeks. Patients with clinically significant gastrointestinal or liver disease. Patients with active granulomatous disease. Patients with urine calcium:creatinine ratio of more than 0.2. Patients who received vitamin D analogs, calcimimetics, or biphosphonates within 4 weeks before screening. Treatment with any one of these medicines during the study is not permitted.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Csaba P. Kovesdy, M.D.
Organizational Affiliation
Salem VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States

12. IPD Sharing Statement

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Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

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