Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

NCT00823303 | Completed Phase 4 Results DMC

• 1 other identifier: 22095
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

Brief Summary

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.

Conditions

Secondary Hyperparathyroidism; Chronic Kidney Disease

Keywords

PTH; Active Vitamin D; hypercalcemia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Confirmed Hypercalcemia

  Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.

  24 week treatment period

Study Arms (2)

Paricalcitol

EXPERIMENTAL

titrated to achieve 40-60% PTH suppression

Drug: Paricalcitol

Calcitriol

ACTIVE COMPARATOR

titrated to achieve 40-60% PTH suppression

Drug: Calcitriol

Interventions

Paricalcitol DRUG

1 mcg daily, adjusted to achieve 40-60% PTH suppression

Also known as: Zemplar

Paricalcitol

Calcitriol DRUG

0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Also known as: Rocaltrol

Calcitriol

Eligibility Criteria

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

You may qualify if:

• Age \>18; Able to give informed consent
• Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation
• intact PTH (iPTH) \>120 pg/ml at baseline
• albumin corrected calcium \> 8.5 mg/dL to \< 10.0 mg/dL at baseline
• Phosphorus \< 4.6 mg/dL at baseline
• If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

You may not qualify if:

• Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)
• Receiving \>50,000 IU per month of ergocalciferol or \> 1000 IU of cholecalciferol per day within the previous 30 days.
• history of primary HPT
• On prednisone \> 30 days within the previous 6 months
• receiving bisphosphonates or calcitonin within the previous 12 months
• Non-elective hospitalization within the previous 30 days.
• Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.
• History of renal or other organ transplant
• History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism
• Receiving cinacalcet within 4 weeks prior to screening.
• An active drug/alcohol dependence or abuse history
• History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator
• Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Henry Ford Hospital: collaborator
• Northwestern University Feinberg School of Medicine: collaborator
• Endeavor Health: collaborator
• Abbott: collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northshore University Health System

Evanston, Illinois, 60201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Coyne DW, Goldberg S, Faber M, Ghossein C, Sprague SM. A randomized multicenter trial of paricalcitol versus calcitriol for secondary hyperparathyroidism in stages 3-4 CKD. Clin J Am Soc Nephrol. 2014 Sep 5;9(9):1620-6. doi: 10.2215/CJN.10661013. Epub 2014 Jun 26.

  PMID: 24970869 RESULT

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Hypercalcemia

Interventions

paricalcitol; Calcitriol

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; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Daniel W. Coyne
• Organization: Washington University School of Medicine

dcoyne@dom.wustl.edu

3143627211

Study Officials

• Daniel W Coyne, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: January 15, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 7, 2014
• Results First Posted: August 5, 2014

Record last verified: 2014-08

Locations

US (4)