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NCT Number: NCT01519947

A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis

This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.

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Key information

Conditions

Anemia, Kidney Disease, Chronic Anemia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C, Aguascalientes, Mexico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult participants, >/= 18 years of age
  • Chronic kidney disease stage III-IV or V
  • Probable start of dialysis within 18 months (pre-dialysis group)
  • Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
  • Adequate iron status
  • Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug

Exclusion criteria

  • Failing renal allograft in place
  • Acute or chronic bleeding within 8 weeks prior to screening
  • Transfusion of red blood cells within 8 weeks prior to screening
  • Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
  • History of seizures, hemoglobinopathies and/or severe liver disease
  • Active malignant disease, except for non-melanoma skin cancer
  • Immunosuppressive therapy in the 12 weeks prior to screening
  • Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
  • Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
  • Pregnant or lactating women

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Participants received 50-250 mcg SC according to local label

Other names: Mircera

Primary outcomes

  1. Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL

    Time frame: Up to approximately 20 months

Secondary outcomes

  1. Change in Hemoglobin Concentration

    Time frame: From baseline to 6 months

  2. Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment

    Time frame: 3 and 6 months

  3. Percentage of Participants With Adverse Events

    Time frame: Up to approximately 20 months

    An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

  4. Percentage of Participants Requiring Dose Adjustments

    Time frame: Up to approximately 20 months

    This outcome measure was not assessed.

  5. Incidence of Red Blood Cell Transfusions

    Time frame: Up to approximately 20 months

    This outcome measure was not assessed.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Comparative Study to Evaluate the Effect of the Altitude on Dosage Requirements of Methoxy Polyethylene Glycol-Epoetin Beta to Correct Hemoglobin Levels in Chronic Renal Anemia in Pre-Dialysis and Dialysis Patients

Acronym: ALTITUD

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2012
Registry last updated
Jun 19, 2019

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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