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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 (ALTITUD)

Primary Purpose

Anemia, Kidney Disease, Chronic

Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Kidney Disease, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
  • Nefros Investigación S.C.
  • Centro de hemodialisis del norte S.C.
  • Hospital Angeles Lindavista;Nefrologia
  • Hospital Star Medica Morelia
  • Unidad De Dialisis La Loma S.C.
  • Hospital Regional De Alta Especialidad De Veracruz; Nephrology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Pre-dialysis, sea level

Dialysis, sea level

Pre-dialysis, >1800 meters

Dialysis, >1800 meters

Arm Description

Participants received 50-250 mcg SC according to local label.

Participants received 50-250 mcg SC according to local label.

Participants received 50-250 mcg SC according to local label.

Participants received 50-250 mcg SC according to local label.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Hemoglobin Concentration
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
Percentage of Participants With Adverse Events
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.
Percentage of Participants Requiring Dose Adjustments
This outcome measure was not assessed.
Incidence of Red Blood Cell Transfusions
This outcome measure was not assessed.

Full Information

First Posted
January 18, 2012
Last Updated
June 17, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01519947
Brief Title
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
Acronym
ALTITUD
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2012 (Actual)
Primary Completion Date
May 30, 2015 (Actual)
Study Completion Date
May 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Kidney Disease, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-dialysis, sea level
Arm Type
Active Comparator
Arm Description
Participants received 50-250 mcg SC according to local label.
Arm Title
Dialysis, sea level
Arm Type
Active Comparator
Arm Description
Participants received 50-250 mcg SC according to local label.
Arm Title
Pre-dialysis, >1800 meters
Arm Type
Experimental
Arm Description
Participants received 50-250 mcg SC according to local label.
Arm Title
Dialysis, >1800 meters
Arm Type
Experimental
Arm Description
Participants received 50-250 mcg SC according to local label.
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera
Intervention Description
Participants received 50-250 mcg SC according to local label
Primary Outcome Measure Information:
Title
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
Time Frame
Up to approximately 20 months
Secondary Outcome Measure Information:
Title
Change in Hemoglobin Concentration
Time Frame
From baseline to 6 months
Title
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
Time Frame
3 and 6 months
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Up to approximately 20 months
Title
Percentage of Participants Requiring Dose Adjustments
Description
This outcome measure was not assessed.
Time Frame
Up to approximately 20 months
Title
Incidence of Red Blood Cell Transfusions
Description
This outcome measure was not assessed.
Time Frame
Up to approximately 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
City
Aguascalientes
ZIP/Postal Code
20210
Country
Mexico
Facility Name
Nefros Investigación S.C.
City
Delegación Coyoacan
ZIP/Postal Code
CP. 04700
Country
Mexico
Facility Name
Centro de hemodialisis del norte S.C.
City
Mexicali
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Hospital Angeles Lindavista;Nefrologia
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Hospital Star Medica Morelia
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
Facility Name
Unidad De Dialisis La Loma S.C.
City
Pureto Vallarta
ZIP/Postal Code
48333
Country
Mexico
Facility Name
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
City
Veracruz
ZIP/Postal Code
91700
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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