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

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Paricalcitol

Calcitriol

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring PTH, Active Vitamin D, hypercalcemia, Chronic Kidney Disease

Eligibility Criteria

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

Inclusion Criteria

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

Exclusion Criteria

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

Sites / Locations

Northwestern University
Northshore University Health System
Henry Ford Hospital
Washington University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paricalcitol

Calcitriol

Arm Description

titrated to achieve 40-60% PTH suppression

Outcomes

Primary Outcome Measures

Confirmed Hypercalcemia

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00823303

First Posted

December 12, 2008

Last Updated

August 4, 2014

Sponsor

Washington University School of Medicine

Collaborators

Henry Ford Hospital, Northwestern University Feinberg School of Medicine, NorthShore University HealthSystem, Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00823303

Brief Title

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

Acronym

PACE

Official Title

A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

Henry Ford Hospital, Northwestern University Feinberg School of Medicine, NorthShore University HealthSystem, Abbott

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

General Design Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT. Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up. Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

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

PTH, Active Vitamin D, hypercalcemia, 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

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paricalcitol

Arm Type

Experimental

Arm Description

titrated to achieve 40-60% PTH suppression

Arm Title

Calcitriol

Arm Type

Active Comparator

Arm Description

titrated to achieve 40-60% PTH suppression

Intervention Type

Drug

Intervention Name(s)

Paricalcitol

Other Intervention Name(s)

Zemplar

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Calcitriol

Other Intervention Name(s)

Rocaltrol

Intervention Description

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

Primary Outcome Measure Information:

Title

Confirmed Hypercalcemia

Description

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

Time Frame

24 week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria 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 Exclusion Criteria 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel W Coyne, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Northshore University Health System

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Henry Ford Hospital

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Washington University

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24970869

Citation

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.

Results Reference

result

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

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