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Optimal Anemia Treatment in End Stage Renal Disease (ERSD) (OPTIMAL)

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ClinicalTrials.gov Identifier: NCT02273570
Recruitment Status : Unknown
Verified September 2015 by Azienda Ospedaliera Sant'Anna.
Recruitment status was:  Recruiting
First Posted : October 24, 2014
Last Update Posted : September 15, 2015
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Azienda Ospedaliera Sant'Anna

Brief Summary:
Clinical study aimed at improving anemia management in End Stage Renal Disease Patient (ESRD) on maintenance Hemodialysis with evidence of Chronic Kidney disease Mineral Bone Disorder (CKD-MBD)

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Drug: standard care Drug: Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Single-center, Open-label, Randomized Study of Anemia Management Improvement in End Stage Renal Disease (ESRD) Patients With Secondary Hyperparathyroidism
Study Start Date : March 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: control
Control group: standard care. The iPTH target in this group is 300-540 pg/ml
Drug: standard care
Standard care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion) to obtain a iPTH of 300-540 pg/ml.
Other Name: Drugs available on the market control iPTH

Experimental: Optimal CKD-MBD control
Optimal CKD-MBD control: in this group the PTH target is150-300 pg/ml to be achieved with a therapeutic algorithm
Drug: Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D
Optimal care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion - see therapeutic algorithm) to obtain a iPTH of less than 300 pg/ml.
Other Name: Drugs available on the market control iPTH




Primary Outcome Measures :
  1. percent reduction in weekly ESA consumption to maintain Hb levels within the recommended range 10.0-11.5 g/dl [ Time Frame: baseline and after 12 months of followup ]
    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


Secondary Outcome Measures :
  1. Change in iron status and storage. [ Time Frame: baseline and after 12 months of followup ]
    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.

  2. Difference in prevalence of cardiac valvular calcification progression detected by echocardiography between groups. [ Time Frame: baseline and after 12 months of followup ]
    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.

  3. Difference in pulse wave velocity assessed by applanation tonometry between groups. [ Time Frame: baseline and after 12 months of followup ]
    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

  4. CKD-MBD control [ Time Frame: baseline and after 12 months of followup ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA.

  • Men and women
  • Age >18 years
  • Maintenance dialysis via Artero-Venous fistula
  • ESA use
  • iPTH between 300-600 pg/ml
  • Hb between 10.0-11.5
  • Kt/V greater/equal than 1.2
  • Signed informed consent prior to the initiation of the study

EXCLUSION CRITERIA: None.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273570


Contacts
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Contact: Antonio Bellasi, MD antonio.bellasi@hsacomo.org

Locations
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Italy
Azienda Ospedaliera Sant'Anna Recruiting
San Fermo della battaglia (CO), Italy, 22020
Contact: Simona Urbano    +39.031.585.8947    comitato.etica@hsacomo.org   
Principal Investigator: Antonio Bellasi, MD         
Principal Investigator: Claudio Minoretti, MD         
Sponsors and Collaborators
Azienda Ospedaliera Sant'Anna
Amgen
Investigators
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Principal Investigator: Antonio Bellasi, MD Azienda Ospedaliera Sant'Anna, Ospedale Sant'Anna-Como

Publications:

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Responsible Party: Azienda Ospedaliera Sant'Anna
ClinicalTrials.gov Identifier: NCT02273570     History of Changes
Other Study ID Numbers: AOSantAnna
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Azienda Ospedaliera Sant'Anna:
Hyperparathyroidism, Secondary
Anemia
Vascular Stiffness
Vascular Calcification
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Failure, Chronic
Anemia
Hyperparathyroidism
Hyperparathyroidism, Secondary
Hematologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Vitamin D
Calcium
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents