Vitamin D Deficiency in Chronic Kidney Disease (CKD) Patients

NCT00958451 | Completed Phase 4

• 1 other identifier: CK0023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

Calcium; Vitamin D deficiency; Chronic Kidney disease

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

Paricalcitol

ACTIVE COMPARATOR

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.

Drug: Paricalcitol; Drug: Ergocalciferol

Ergocalciferol

ACTIVE COMPARATOR

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.

Drug: Paricalcitol; Drug: Ergocalciferol

Interventions

Paricalcitol DRUG

1. Patients will receive 1mcg once daily orally if iPTH is less than 500pg/ml; 2. Patients will receive 2mcg once daily orally if iPTH is more than 500pg/ml. Duration of administration will be 16 weeks.

Ergocalciferol; Paricalcitol

Ergocalciferol DRUG

1. 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. 2. 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. 3. If baseline 25 OHD level is between 16 and 30ng/ml: Ergocalciferol 50,000 units orally once every 4 weeks for 16 weeks.

Ergocalciferol; Paricalcitol

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salem Veterans Affairs Medical Center: lead
• Abbott: collaborator

Study Sites (1)

VA Medical Center

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Vitamin D Deficiency

Interventions

paricalcitol; Ergocalciferols

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; 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; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Csaba P. Kovesdy, M.D.

  Salem VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 24, 2011

Record last verified: 2009-08

Locations

US (1)