Efficacy and Safety of Alfacalcidol Compared to Calcitriol for Treatment of Secondary Hyperparathyroidism

NCT01115543 | Completed Phase 4 DMC

• 1 other identifier: 358/2551
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study was performed to determine whether calcitriol provides a therapeutic advantage to alfacalcidol for treatment of secondary hyperparathyroidism in ESRD patients.

Conditions

Secondary Hyperparathyroidism; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of intact parathyroid hormone levels

  48 weeks

Secondary Outcomes (1)

• hypercalcemia and hyperphosphatemia

  48 weeks

Study Arms (2)

calcitriol

ACTIVE COMPARATOR

The subjects were randomized to receive calcitriol in a dose-escalating fashion for up to 24 weeks.

Drug: alfacalcidol and calcitriol

alfacalcidol

EXPERIMENTAL

Drug: alfacalcidol and calcitriol

Interventions

alfacalcidol and calcitriol DRUG

The initial dose of alfacalcidol was twice that of calcitriol.Both were adjusted to control intact PTH within the ranges of 150-300 pg/ml.

alfacalcidol; calcitriol

Eligibility Criteria

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

You may qualify if:

• Chronic hemodialysis patients who underwent scheduled hemodialysis for at least 3 months with secondary hyperparathyroidism (intact PTH levels \> 300 pg/mL)

You may not qualify if:

• (1) age \< 18 years (2) hypersensitivity to calcitriol or alfacalcidol (3) inadequate dialysis \[defined as single-pooled Kt/V (sp-Kt/V) \<1.2 and \<2.0 for thrice a week and twice a week hemodialysis\] (4) corrected serum calcium \>10.2 mg/dL or serum phosphate \>6 mg/dL after adjusting dialysate calcium and phosphate binders (5) diameter of parathyroid gland \>10 mm (6) pregnancy or lactation (7) liver cirrhosis (8) active kidney transplantation (9) previous parathyroidectomy (10) malignancy or chronic infection/inflammation.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Medical School

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Interventions

alfacalcidol; Calcitriol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2010
• First Posted: May 4, 2010
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 4, 2010

Record last verified: 2010-05

Locations

TH (1)