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Clinical Trials/EUCTR2006-004959-38-DE
EUCTR2006-004959-38-DE
Active, not recruiting
Not Applicable

A prospective multicenter, open-label, randomised, cross-over study to compare the efficacy and safety of Fosrenol and Sevelemer Hydrochloride in patients receiving hemodialysis for end stage renal disease

Shire Development Inc0 sites214 target enrollmentApril 18, 2007
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ConditionsHyperphosphataemia in patients with end-stage renal disease receiving haemodialysisMedDRA version: 8.1Level: LLTClassification code 10020712Term: Hyperphosphatemia
DrugsFosrenol 750mg Chewable TabletsFosrenol 1000mg Chewable TabletsRenagel 800mg film-coated tablets

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hyperphosphataemia in patients with end-stage renal disease receiving haemodialysis
Sponsor
Shire Development Inc
Enrollment
214
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 18, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Shire Development Inc

Eligibility Criteria

Inclusion Criteria

  • •Aged 18 or over
  • •Females must be non\-pregnant and agree to comply with the contraceptive requirements of the protocol
  • •Must have CKD Stage 5 and and have been receiving haemodialysis two times or three times a week for at least 2 months
  • •Being treated with a monotherapy calcium based phosphate binder or a combination therapy not containing Fosrenol or sevelamer hydrochloride. Treatment\-naiive patients are permitted to enter the study providing serum phosphorus levels are greater or equal 6\.0 mg/dL (1\.92 mmol/L)
  • •must understand and be able and willing and likely to fully comply with study procedures and restrictions
  • •written, signed and dated informed consent to praticipate in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients who require treatment with cinacalcet hydrochloride, or with compounds containing phosphate or magnesium, aluminium or calcium (except as indicated in section 6\.4\.1 of the protocol) that are used as a phosphate binder.
  • •Any significant GI surgery or GI disorders (including active, uncontrolled peptic ulcer, Crohns disease, GI bleed in last 6 months, past or present GI malignancy
  • •Cirrhosis or other clinically relevant liver disease
  • •Intact PTH \>500 pg/ml
  • •Serum calcium \<8\.8 mg/dL (\<2\.20mmol/L)
  • •Life threatening malignancy or current multiple myeloma
  • •known to be HIV positive
  • •Hypersensitivity to investigational products
  • •Alcohol or other substance abuse 1 year prior to screening
  • •Patients must not have used another investigational product or taken part in a clinical trial within the last 30 days prior to enrollment

Outcomes

Primary Outcomes

Not specified

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