Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

NCT00664430 | Terminated Phase 4 Results

• 1 other identifier: W10-131
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of paricalcitol in participants with moderate to severe secondary hyperparathyroidism (SHPT) undergoing hemodialysis who are resistant to treatment with calcitriol.

Conditions

Secondary Hyperparathyroidism; Dialysis

Keywords

Dialysis; Calcitriol Resistant; Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values

  This outcome was measured at Visit 15, which could occur at different timepoints from study start, depending on the duration of each study period for each participant, relative to values on Visit 4. For participants who did not perform visit 4, the reduction of the PTH levels were to be assessed relative to visit 5 values.

  Up to Week 24

Secondary Outcomes (2)

• Changes in Bone Remodeling Markers Over Time

  Every 3 months

• Number of Participants With Adverse Events

  Up to 1 year

Study Arms (1)

Calcitriol challenge followed by paricalcitol

OTHER

Participants began a controlled calcitriol therapy period (calcitriol challenge) to confirm calcitriol resistance. After this period, those who failed to reduce PTH (according to parameters in protocol) initiated paricalcitol therapy.

Drug: Calcitriol; Drug: Paricalcitol

Interventions

Calcitriol DRUG

Initial doses determined according to the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) guideline (Am J Kidney Dis 2003;42(4)Suppl 3:S1-S201). During therapy, calcitriol dose may be modified by 0.5 - 1 mcg at 2- to 4-week intervals.

Also known as: Calcijex

Calcitriol challenge followed by paricalcitol

Paricalcitol DRUG

Dose calculated by 0.04 to 0.1 microgram per kilogram (mcg/kg). Paricalcitol will be administered intravenously after the participants' dialysis. The paricalcitol dose will be titrated every 2 weeks until iPTH presents a reduction or up to 4 months, after which it will be adjusted monthly based on serum PTH, calcium, phosphorus and albumin measurements. Dosing may be modified by 2-4 mcg increments at 2- to 4-week intervals.

Also known as: ABT-358, Zemplar, Paracalcitol

Calcitriol challenge followed by paricalcitol

Eligibility Criteria

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

You may qualify if:

• Male and female participants \> 18 years of age, with chronic kidney disease (CKD) stage V;
• Participants with diagnosis of calcitriol resistance defined as: Episodes of hypercalcemia and/or hyperphosphatemia (defined as an episode of calcium or phosphorus above Upper Limit of Normal or documented by medical history stating that the treatment with calcitriol was discontinued due to hypercalcemia and/or hyperphosphatemia) that precludes treatment continuation and/or persistent PTH above 600pg/mL during the calcitriol therapy;
• PTH value at screening visit between 600 pg/mL and 2,000 pg/mL;
• Stable clinical conditions;
• Participant has voluntarily consented to participate in the study, by signing and dating an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and all his questions about the study have been elucidated. The informed consent must be signed before any study-specific procedures are performed.

You may not qualify if:

• Previous parathyroidectomy;
• Presence of hypercalcemia (corrected Ca \> 10.5 mg/dL) and/or hyperphosphatemia (P \> 6.0 mg/dL) and/or Ca x P product \> 60, at screening visit (corrected Ca calculated by: \[4 - participant's serum albumin (g/dL)\] x 0.8 + participant's serum Ca value);
• Severe and/or unstable clinical conditions, e.g., congestive heart failure, advanced cancer, advanced HIV disease, severe endocrinopathies, uncompensated diabetes mellitus, life-threatening cardiac arrhythmias, etc;
• Abnormal liver tests (\> 1.5 times above upper limit of normal);
• Pregnant or breast-feeding women;
• Evidence of vitamin D toxicity;
• Known hypersensitivity to any study drug components.

Sponsors & Collaborators

• Abbott: lead
• Statistika Consultoria Ltda: collaborator

Study Sites (2)

Site Reference ID/Investigator# 7118

São Paulo, 04039-001, Brazil

Location

Site Reference ID/Investigator# 7114

São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Calcitriol; paricalcitol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination leading to no efficacy evaluation. All adverse events occurred during calcitriol challenge phase.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Lino Rodrigues, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 23, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 20, 2012
• Results First Posted: August 18, 2010

Record last verified: 2012-01

Locations

BR (2)