Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

End-Stage Renal Disease Clinical Trial

Official title:

A Prospective, Multicenter Study to Evaluate the Safety of Paricalcitol Capsules as Determined by Hypercalcemia in Pediatric Patients Ages 0 to 16 With Chronic Kidney Disease (CKD) Stage 5 Receiving Peritoneal Dialysis (PD) Within Current Clinical Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01134315
• Other study ID #: P12-053
• Status: Terminated
• Phase: N/A
• First received: May 28, 2010
• Last updated: May 17, 2013
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Description:

Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

1. Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.

2. The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.

3. The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.

4. Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.

5. Patient has received paricalcitol or calcitriol for a minimum of 10 days.

Exclusion Criteria:

1. Patient is scheduled for a kidney transplant within 3 months.

2. Patient is expected to stop peritoneal dialysis within 3 months.

3. Patient is expected to transfer to hemodialysis within 3 months.

4. Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Paricalcitol

• Calcitriol

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 26749	Akron	Ohio
United States	Site Reference ID/Investigator# 26748	Atlanta	Georgia
United States	Site Reference ID/Investigator# 39973	Baltimore	Maryland
United States	Site Reference ID/Investigator# 37082	Birmingham	Alabama
United States	Site Reference ID/Investigator# 26769	Boston	Massachusetts
United States	Site Reference ID/Investigator# 28526	Charlottesville	Virginia
United States	Site Reference ID/Investigator# 26751	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 26765	Columbus	Ohio
United States	Site Reference ID/Investigator# 26768	Detroit	Michigan
United States	Site Reference ID/Investigator# 26762	Gainesville	Florida
United States	Site Reference ID/Investigator# 26747	Kansas City	Missouri
United States	Site Reference ID/Investigator# 40382	Madison	Wisconsin
United States	Site Reference ID/Investigator# 37582	New Orleans	Louisiana
United States	Site Reference ID/Investigator# 28528	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 28529	Orlando	Florida
United States	Site Reference ID/Investigator# 26763	Portland	Oregon
United States	Site Reference ID/Investigator# 26758	Seattle	Washington
United States	Site Reference ID/Investigator# 26759	Wauwatosa	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Incidence of Hypercalcemia	Hypercalcemia was defined as calcium >10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.	Monitored from time of informed consent through end of study + 30 days (total of 745 days).	Yes
Secondary	Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs	AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.	Monitored from time of informed consent through end of study + 30 days (total of 745 days).	Yes
Secondary	Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes
Secondary	Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes
Secondary	Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes
Secondary	Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes
Secondary	Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes
Secondary	Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)	Normal ranges for these chemistry measurements varied according to the age of the participant.	Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])	Yes

External Links

•   Link