NCT02273570

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

June 27, 2014

Last Update Submit

September 12, 2015

Conditions

Hyperparathyroidism, Secondary

Keywords

Hyperparathyroidism, SecondaryAnemiaVascular StiffnessVascular Calcification

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in iron status and storage.

    baseline and after 12 months of followup

  • Difference in prevalence of cardiac valvular calcification progression detected by echocardiography between groups.

    baseline and after 12 months of followup

  • Difference in pulse wave velocity assessed by applanation tonometry between groups.

    baseline and after 12 months of followup

  • CKD-MBD control

    baseline and after 12 months of followup

Study Arms (2)

control

ACTIVE COMPARATOR

Control group: standard care. The iPTH target in this group is 300-540 pg/ml

Drug: standard care

Optimal CKD-MBD control

EXPERIMENTAL

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

Interventions

standard careDRUG

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.

Also known as: Drugs available on the market control iPTH
control
Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin DDRUG

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.

Also known as: Drugs available on the market control iPTH
Optimal CKD-MBD control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Sant'Anna

San Fermo Della Battaglia (CO), 22020, Italy

RECRUITING

Related Publications (8)

  • Capuano A, Serio V, Pota A, Memoli B, Andreucci VE. Beneficial effects of better control of secondary hyperparathyroidism with paricalcitol in chronic dialysis patients. J Nephrol. 2009 Jan-Feb;22(1):59-68.

    PMID: 19229819BACKGROUND

  • Ebben JP, Gilbertson DT, Foley RN, Collins AJ. Hemoglobin level variability: associations with comorbidity, intercurrent events, and hospitalizations. Clin J Am Soc Nephrol. 2006 Nov;1(6):1205-10. doi: 10.2215/CJN.01110306. Epub 2006 Sep 6.

    PMID: 17699349BACKGROUND

  • Fishbane S, Berns JS. Hemoglobin cycling in hemodialysis patients treated with recombinant human erythropoietin. Kidney Int. 2005 Sep;68(3):1337-43. doi: 10.1111/j.1523-1755.2005.00532.x.

    PMID: 16105069BACKGROUND

  • Gilbertson DT, Ebben JP, Foley RN, Weinhandl ED, Bradbury BD, Collins AJ. Hemoglobin level variability: associations with mortality. Clin J Am Soc Nephrol. 2008 Jan;3(1):133-8. doi: 10.2215/CJN.01610407. Epub 2007 Nov 28.

    PMID: 18045862BACKGROUND

  • Lacson E Jr, Ofsthun N, Lazarus JM. Effect of variability in anemia management on hemoglobin outcomes in ESRD. Am J Kidney Dis. 2003 Jan;41(1):111-24. doi: 10.1053/ajkd.2003.50030.

    PMID: 12500228BACKGROUND

  • Pisoni RL, Bragg-Gresham JL, Young EW, Akizawa T, Asano Y, Locatelli F, Bommer J, Cruz JM, Kerr PG, Mendelssohn DC, Held PJ, Port FK. Anemia management and outcomes from 12 countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2004 Jul;44(1):94-111. doi: 10.1053/j.ajkd.2004.03.023.

    PMID: 15211443BACKGROUND

  • Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 2009 Aug;(113):S1-130. doi: 10.1038/ki.2009.188.

    PMID: 19644521BACKGROUND

  • National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003 Oct;42(4 Suppl 3):S1-201. No abstract available.

    PMID: 14520607BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryAnemiaVascular Calcification

Interventions

Standard of Carecalcium acetateVitamin D

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesHematologic DiseasesHemic and Lymphatic DiseasesCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Antonio Bellasi, MD

    Azienda Ospedaliera Sant'Anna, Ospedale Sant'Anna-Como

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Bellasi, MD

CONTACT

antonio.bellasi@hsacomo.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2014

First Posted

October 24, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations

IT(1)