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OpenTrials
Completed

NCT Number: NCT00745589

Sevelamer Hydrochloride in Peritoneal Dialysis Patients

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.

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Key information

Conditions

Endstage Renal Disease

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevelamer Hydrochloride

Drug

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

Primary outcomes

  1. Changes in coronary artery, aortic valve, mitral annulus calcium scores

    Time frame: over 24 months

    Vascular and valvular calcium scores

Secondary outcomes

  1. Changes in aortic pulse wave velocity

    Time frame: over 24 months

    arterial stiffness parameter

  2. annualized percentage change in Coronary artery calcium score

    Time frame: over 12 months

    annualized percentage change in calcium score

  3. Changess in serum T50

    Time frame: over 24 months

    serum calcification propensity measure

  4. Changes in serum calcium, phosphate

    Time frame: over 24 months

    biochemical parameters

  5. Changes in alkaline phosphatase

    Time frame: over 24 months

    biochemical parameters

  6. Changes in intact parathyroid hormone

    Time frame: over 24 months

    biochemical parameters

  7. Changes in low density lipoprotein-cholesterol

    Time frame: over 24 months

    biochemical parameters

  8. Changes in C-reactive protein

    Time frame: over 24 months

    biochemical parameters

  9. Changes in systolic blood pressure

    Time frame: over 24 months

    blood pressure

  10. Changes in diastolic blood pressure

    Time frame: over 24 months

    blood pressure

  11. Changes in Forearm, femur and spine bone mineral density, T score and Z score

    Time frame: over 24 months

    Bone mineral density related parameters

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients

Acronym: SERENE

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Sep 3, 2008
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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