Effectiveness of Oral Alfacalcidol for Secondary Hyperparathyroidism in Chronic Hemodialysis Patients.

NCT ID: NCT02895061

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

Brief Summary

Primary objective was to evaluate the efficacy between daily and pulse oral alfacalcidol treatment of SHPT in chronic hemodialysis patients, a 12-week treatment. Secondary objective was to observe the adverse effects between these two treatment regimens.

Detailed Description

ESRD patients with secondary hyperparathyroidism in 3 hemodialysis centers were enrolled. They were assigned to either oral daily or pulse (trice a week) alfacalcidol treatments using block-of-4 randomization. Alfacalcidol in both groups were equal at the dose of 6 microgram per week. Clinical and laboratory data were obtained at baseline and were monitored every 4 weeks for 12 weeks. Primary outcome was the difference of the mean PTH reduction between two groups at the end of the study by unpaired-T test. All possible adverse events were carefully monitored.

Conditions

Alfacalcidol, Secondary Hyperparathyroidism, Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A: Daily

A: oral daily alfacalcidol treatments total 6 microgram/week

Group Type: EXPERIMENTAL

Alfacalcidol

Intervention Type: DRUG

Alfacalcidol 1 microgram/capsule

B: Pulse

B: pulse (trice a week) alfacalcidol treatments total 6 microgram/week

Group Type: EXPERIMENTAL

Alfacalcidol

Intervention Type: DRUG

Alfacalcidol 1 microgram/capsule

Interventions

Alfacalcidol

Alfacalcidol 1 microgram/capsule

Intervention Type: DRUG

Other Intervention Names

oral daily alfacalcidol treatments total 6 microgram/week

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 y ESRD on HD KT/V ≥ 3.6/wk 2˚HPT Stable in P binder for 4 wk

Exclusion Criteria

• Alfacalcidol allergy Serum Ca ≥ 10.5 mg/dL Serum P ≥ 5.5 mg/dL Pregnancy On phenytoin, phenobarbital

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Gu Y, Ding F, Chen N, Mei CL, Qian JQ, Wang XY, Shi W, Hou FF, Li XW, Wang M, Chen YP. Comparisons between oral pulse alfacalcidol therapy and daily therapy in maintenance hemodialysis patients with secondary hyperparathyroidism: a randomized, controlled, and multicenter study. Ren Fail. 2005;27(2):205-12.

Reference Type: BACKGROUND

PMID: 15807187 (View on PubMed)

Tarrass F, Yazidi A, Sif H, Zamd M, Benghanem MG, Ramdani B. A randomized trial of intermittent versus continuous oral alfacalcidol treatment of hyperparathyroidism in end-stage renal disease. Clin Nephrol. 2006 Jun;65(6):415-8. doi: 10.5414/cnp65415.

Reference Type: RESULT

PMID: 16792136 (View on PubMed)

Llach F, Yudd M. Pathogenic, clinical, and therapeutic aspects of secondary hyperparathyroidism in chronic renal failure. Am J Kidney Dis. 1998 Oct;32(2 Suppl 2):S3-12. doi: 10.1053/ajkd.1998.v32.pm9808139. No abstract available.

Reference Type: RESULT

PMID: 9808139 (View on PubMed)

Other Identifiers

PMK-0007

Identifier Type: -

Identifier Source: org_study_id