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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Chris Freitag


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Be Part of Research - Trial Details - Safety and efficacy of subcutaneous HMR4396 for the management of anaemia in subjects with chronic renal failure
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Safety and efficacy of subcutaneous HMR4396 for the management of anaemia in subjects with chronic renal failure

Not Recruiting

Open to: All Genders

Age: Adult

Basingstoke

Medical Conditions

Chronic Kidney Disease (CKD)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Not provided at time of registration and not expected to be available in the future

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Oct 1998 07 Jun 2000

Publications

2009 Results article in https://pubmed.ncbi.nlm.nih.gov/19243619/ results (added 04/01/2021)

Interventional

Intervention Type : Drug
Intervention Description : The intervention was administration of HMR4396, given subcutaneously 1, 2, or 3 times weekly for up to 52 weeks, starting at the same dose as the previous epoetin in three patient groups:1. CKD not on dialysis (pre-dialysis)2. CKD on haemodialysis3. CKD on peritoneal dialysis

The main comparison was the ability to maintain the Haemoglobin (Hb) concentration over the duration of the trial.




You can take part if:



You may not be able to take part if:


1. Uncontrolled hypertension 2. For haemodialysis subjects, missed more than three dialysis sessions in the 30 days before signing informed consent 3. One or more doses of epoetin missed or withheld by physician order in the 14 days before signing informed consent 4. Concomitant unrelated illness that could reduce life expectancy to less than 12 months (such as malignancy, immune deficiency, myocardial infarction or cerebrovascular accident within 30 days before signing informed consent) 5. Thrombocytopenia (platelet count less than 75,000/mm^3) 6. Active bleeding 7. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) within 30 days before signing informed consent 8. Androgen therapy within 30 days before signing informed consent 9. Current drug abuse10. Known Human Immunodeficiency Virus (HIV) infection from medical history 11. Treatment with any investigational drug within 30 days before signing informed consent 12. Breastfeeding 13. Pregnancy at enrolment or plans to become pregnant during the study. It was required that absence of pregnancy be documented by serum test before exposure to HMR4396 or any other study procedure with potential risk to a foetus14. Childbearing potential. Absence of childbearing potential was defined as being surgically sterile, at least one year post-menopausal, or using a medically accepted (prescription or nonprescription) method of contraception15. History of hypersensitivity to HMR4396 or to drugs with similar chemical structures 16. Impaired hepatic function, defined as a pre-study value for Aspartate Aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase [SGOT]) or Alanine Aminotransferase (ALT) (Serum Glutamic Pyruvic Transaminase [SGPT]) exceeding three times the upper limit of the normal range for the central laboratory 17. Clinically relevant haematologic, cardiovascular, hepatic, neurologic, endocrine, infectious, inflammatory or other major systemic disease making implementation of the protocol or interpretation of the study results difficult 18. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 19. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study20. Likelihood that the subject would require treatment during the study period with drugs not permitted by the protocol21. Previous treatment with HMR4396


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Shire Pharmaceuticals contact for trial
    Basingstoke
    RG24 8EP

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Dr Chris Freitag



The study is sponsored by Hoechst Marion Roussel (Shire Pharmaceuticals) (France) and funded by Hoechst Marion Roussel (France).




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Read full details for Trial ID: ISRCTN68321818
Last updated 04 January 2021

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