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SERENE: Sevelamer Hydrochloride in Peritoneal Dialysis Patients

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT00745589
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
78
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.

Condition or Disease Intervention/Treatment Phase
  • Drug: sevelamer hydrochloride
 N/A

Detailed Description

Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in ESRD patients and is largely attributed to the increased prevalence of vascular calcification.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: higher dose sevelamer

first-line higher dose sevelamer hydrochloride

Drug: sevelamer hydrochloride
First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)
Other Names:
  • Renagel

    		•
    Active Comparator: low dose sevelamer

    second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate

    Drug: sevelamer hydrochloride
    First-line higher dose (that is, 800mg TDS and up to a maximum of 1200mg TDS) sevelamer hydrochloride will be compared against low dose second-line sevelamer hydrochloride (that is, fixed dose of 400mg TDS)
    Other Names:
  • Renagel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in coronary artery, aortic valve, mitral annulus calcium scores [over 24 months]

      Vascular and valvular calcium scores

    Secondary Outcome Measures

    1. Changes in aortic pulse wave velocity [over 24 months]

      arterial stiffness parameter

    2. annualized percentage change in Coronary artery calcium score [over 12 months]

      annualized percentage change in calcium score

    3. Changess in serum T50 [over 24 months]

      serum calcification propensity measure

    4. Changes in serum calcium, phosphate [over 24 months]

      biochemical parameters

    5. Changes in alkaline phosphatase [over 24 months]

      biochemical parameters

    6. Changes in intact parathyroid hormone [over 24 months]

      biochemical parameters

    7. Changes in low density lipoprotein-cholesterol [over 24 months]

      biochemical parameters

    8. Changes in C-reactive protein [over 24 months]

      biochemical parameters

    9. Changes in systolic blood pressure [over 24 months]

      blood pressure

    10. Changes in diastolic blood pressure [over 24 months]

      blood pressure

    11. Changes in Forearm, femur and spine bone mineral density, T score and Z score [over 24 months]

      Bone mineral density related parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ESRD patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only

    • Patients who cannot afford to self-pay sevelamer hydrochloride.

    • Patients who provided informed consent for the study

    Exclusion Criteria:

    • Patients with underlying active malignancy

    • Patients with cyanotic congenital heart disease

    • Patients with poor general condition

    • Patients with plan for living related kidney transplant within coming 1 year

    • Female patients with pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen Mary Hospital, Tung Wah Hospital Hong Kong Hong Kong 0000

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Angela YM Wang, MD, PhD, Queen Mary Hospital, University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Angela Yee-Moon Wang, Dr., The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT00745589
    Other Study ID Numbers:
    • A111-104
    First Posted:
    Sep 3, 2008
    Last Update Posted:
    Jun 18, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dr. Angela Yee-Moon Wang, Dr., The University of Hong Kong
    vascular,
    valvular calcification,
    phosphate binder,
    sevelamer,
    endstage renal disease
    peritoneal dialysis
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic
    Sevelamer

    Study Results

    No Results Posted as of Jun 18, 2020