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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Secondary Hyperparathyroidism Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypercalcemia Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern University, Chicago, Illinois, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paricalcitol

Drug

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

Other names: Zemplar

calcitriol

Drug

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

Other names: Rocaltrol

Primary outcomes

Confirmed Hypercalcemia

Time frame: 24 week treatment period

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Abbott
Endeavor Health
Henry Ford Hospital
Northwestern University

Registry information

Official study 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

Acronym: PACE

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Jan 15, 2009
Registry last updated: Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed