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

Chronic Kidney Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823303
• Other study ID #: 22095
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2008
• Last updated: August 4, 2014
• Start date: February 2009
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Age >18; Able to give informed consent

2. Chronic kidney disease, and estimated GFR 15 to 60 ml/min using the abbreviated MDRD equation

3. intact PTH (iPTH) >120 pg/ml at baseline

4. albumin corrected calcium > 8.5 mg/dL to < 10.0 mg/dL at baseline

5. Phosphorus < 4.6 mg/dL at baseline

6. If on a phosphorus binder; no change in dose within the 4 weeks prior to screening

Exclusion Criteria

1. Receiving any active form of vitamin D within 4 weeks prior to screening (calcitriol, doxercalciferol; paricalcitol; alfacalcidol)

2. Receiving >50,000 IU per month of ergocalciferol or > 1000 IU of cholecalciferol per day within the previous 30 days.

3. history of primary HPT

4. On prednisone > 30 days within the previous 6 months

5. receiving bisphosphonates or calcitonin within the previous 12 months

6. Non-elective hospitalization within the previous 30 days.

7. Expected to initiate dialysis or receive a kidney transplant within the next 6 mo.

8. History of renal or other organ transplant

9. History of parathyroidectomy or previous diagnosis of primary hyperparathyroidism

10. Receiving cinacalcet within 4 weeks prior to screening.

11. An active drug/alcohol dependence or abuse history

12. History of non-compliance with visits or medications that preclude study compliance in the opinion of the investigator

13. Pregnant, or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Paricalcitol
1 mcg daily, adjusted to achieve 40-60% PTH suppression
• Calcitriol
0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Northshore University Health System	Evanston	Illinois
United States	Washington University	St. Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Washington University School of Medicine	Abbott, Feinberg School of Medicine, Northwestern University, Henry Ford Hospital, NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Hypercalcemia	Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.	24 week treatment period	Yes