Renal Osteodystrophy Clinical Trial
Official title:
A Multicenter, Randomized, Placebo-controlled, Double-blind, 12-month Study to Assess the Effects of an Oral Calcimimetic Agent (AMG 073) on Renal Osteodystrophy in Hemodialysis Patients With Secondary Hyperparathyroidism
Verified date | May 2013 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.
Status | Completed |
Enrollment | 45 |
Est. completion date | August 2003 |
Est. primary completion date | August 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age of greater - Using effective contraceptive measures - iPTH greater than or equal to 300 pg/mL - Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9 - Stable hemodialysis for 1 month prior to day 1 Exclusion Criteria: - Any unstable medical condition - Pregnant or nursing women Recent parathyroidectomy - Change in Vitamin D therapy - Recent MI, Seizure, Malignancy, GI Disorder - Inability to swallow tablets |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Amgen |
Malluche HH, Monier-Faugere MC, Wang G, Frazã O JM, Charytan C, Coburn JW, Coyne DW, Kaplan MR, Baker N, McCary LC, Turner SA, Goodman WG. An assessment of cinacalcet HCl effects on bone histology in dialysis patients with secondary hyperparathyroidism. C — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effects of AMG 073 compared with placebo on renal osteodystrophy as assessed by bone histomorphometry | entire study | No | |
Secondary | To evaluate the effects of AMG 073 compared with placebo on intact parathyroid hormone (iPTH), bone-specific alkaline phosphatase (BALP), serum N-Telopeptide (N-Tx), and calcium x phosphorus product concentrations | entire study | No | |
Secondary | To evaluate the feasibility of measuring physical activity with accelerometry | entire study | No | |
Secondary | To evaluate the safety and tolerability of AMG 073 compared with placebo | entire study | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03960437 -
The Effect of Etelcalcetide on CKD-MBD
|
Phase 2 | |
Recruiting |
NCT03716128 -
Diagnosis of Renal Osteodystrophy in Patients With Reduced Renal Function
|
||
Recruiting |
NCT02147782 -
Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency
|
||
Completed |
NCT00108394 -
Osteopenia and Renal Osteodystrophy: Evaluation and Management
|
Phase 4 | |
Completed |
NCT00560300 -
Regulation of Bone Formation in Renal Osteodystrophy
|
Phase 2 | |
Active, not recruiting |
NCT00752401 -
Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients
|
Phase 3 | |
Completed |
NCT00364234 -
Low Magnitude Mechanical Stimuli Effects on Bone Structure in ESRD
|
N/A | |
Completed |
NCT00859612 -
Renal Osteodystrophy: A Fresh Approach
|
N/A | |
Completed |
NCT00004340 -
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
|
Phase 2 | |
Completed |
NCT01675089 -
Zoledronic Acid to Prevent Bone Loss After Kidney Transplantation
|
Phase 4 | |
Not yet recruiting |
NCT01382966 -
Serum Sclerostin Levels, Cardiovascular Parameters and Carpal Tunnel Syndrome in Maintenance Hemodialysis Patients
|
N/A | |
Completed |
NCT03626246 -
Pathogenesis of Compromised Bone Quality and Mechanics in Chronic Kidney Disease
|
||
Terminated |
NCT00374712 -
Klotho Gene Polymorphism in Dialyzed Patients With Hyperphosphatemia
|
N/A | |
Terminated |
NCT03960554 -
The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients
|
Phase 2 | |
Recruiting |
NCT02556216 -
Systematic Study of Parameters of Chronic Kidney Disease Mineral and Bone Disorder (CKD-MBD)
|
N/A | |
Recruiting |
NCT05880914 -
Precision Medicine Approaches to Renal Osteodystrophy
|
Early Phase 1 | |
Withdrawn |
NCT01665651 -
Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
|
Phase 2 |