Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compare the Efficacy of Cinacalcet vs Traditional Vitamin D for Secondary Hyperparathyroidism (SHPT) Among Subjects Undergoing Hemodialysis

NCT01181531

Hyperparathyroidism, Secondary

COMPLETED PHASE4

Cinacalcet in Management of Secondary Hyperparathyroidism in Haemodialysis Patients

NCT02338934

Secondary Hyperparathyroidism

UNKNOWN PHASE4

Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

NCT01143987

Hyperparathyroidism Arterial Stiffness

COMPLETED PHASE4

Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

NCT00446329

Secondary Hyperparathyroidism

TERMINATED PHASE4

Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment

NCT04637360

Hyperparathyroidism; Secondary, Renal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Secondary Hyperparathyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cinacalcet

stepwise dose of cinacalcet + regular medical medication including vit D

Group Type EXPERIMENTAL

cinacalcet

Intervention Type DRUG

cinacalcet 25mg qd or 50 mg qd

Control

conventional treatment for secondary HPT including vit D and phosphate binder

Group Type ACTIVE_COMPARATOR

control

Intervention Type DRUG

vit D + P binder

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cinacalcet

cinacalcet 25mg qd or 50 mg qd

Intervention Type DRUG

control

vit D + P binder

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Peritoneal dialysis patients with secondary HPT(iPTH \> 300 pg/mL)
* \> 18 yr of age, \< 70
* had receive PD for \> 3 mo,
* intact PTH level \> 300 pg/ml and \<1000 pg/ml
* albumin corrected Ca level \>= 9.0 mg/dL

Exclusion Criteria

* pregnant or breast-feeding,
* had undergone parathyroidectomy within previous 3 mo,
* are involved in other clinical trial within 30 d
* had received cinacalcet therapy previously.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No