CompletedPhase 4

A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

Bulgaria58 participantsStarted 2004-10

Plain-language summary

This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients 18-65 years of age * Chronic renal failure (Stages I-III) * No previous epoetin therapy Exclusion Criteria: * Poorly controlled hypertension * History or evidence of malignancy * Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug * Women who are pregnant or breastfeeding

What they're measuring

Percentage of participantss who change to once weekly NeoRocormon

Timeframe: 10 months

Percentage of participants with local intolerabilities (pain/allergic reactions)

Timeframe: 10 months

Percentage of participants who withdrew due to inability to use RecoPen

Timeframe: 10 months

Percentage of participants who changed dose during treatmnent

Timeframe: 10 months

Trial details

NCT IDNCT02569515

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-07

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