| Trial ID: | L1498 |
| Source ID: | NCT02273570
|
| Associated Drug: |
Standard Care
|
| Title: |
Optimal Anemia Treatment in End Stage Renal Disease (ERSD)
|
| Acronym: |
OPTIMAL
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperparathyroidism, Secondary
|
| Interventions: |
DRUG: standard care|DRUG: Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D
|
| Outcome Measures: |
Primary: percent reduction in weekly ESA consumption to maintain Hb levels within the recommended range 10.0-11.5 g/dl, Primary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a lower ESA dose use to achieve the target Hb of 10.0-11.5 g/dl, baseline and after 12 months of followup | Secondary: Change in iron status and storage., Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better iron storage and mobilization., baseline and after 12 months of followup|Difference in prevalence of cardiac valvular calcification progression detected by echocardiography between groups., Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with cardiac valves deposition and progression attenuation., baseline and after 12 months of followup|Difference in pulse wave velocity assessed by applanation tonometry between groups., Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with arterial stiffness increase attenuation, baseline and after 12 months of followup|CKD-MBD control, Secondary objective: to test whether a tighter PTH control to achieve a PTH level lower than 300 pg/ml vs PTH levels between 300-540 pg/ml is associated with a better CKD-MBD control, baseline and after 12 months of followup
|
| Sponsor/Collaborators: |
Sponsor: Azienda Ospedaliera Sant'Anna | Collaborators: Amgen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
|
| Start Date: |
2015-03
|
| Completion Date: |
2017-03
|
| Results First Posted: |
|
| Last Update Posted: |
2015-09-15
|
| Locations: |
Azienda Ospedaliera Sant'Anna, San Fermo della battaglia (CO), 22020, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02273570
|
