Anemia, Kidney Disease, ChronicPhase 4ALTITUDNCT01519947

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

A Phase 4 study testing Methoxy polyethylene glycol-epoetin beta in people with Anemia, Kidney Disease, Chronic, run by Hoffmann-La Roche at 7 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Kidney Disease, Chronic
What is being tested?: Methoxy polyethylene glycol-epoetin beta
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 7 sitesMexico
Study dates: 30 May 2012to 30 May 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Mexico7 sites

Clínica San Cosme Centro Especializado en el Tratamiento de Enfermedades Renales S.C
Aguascalientes, 20210
Nefros Investigación S.C.
Delegación Coyoacan, CP. 04700
Centro de hemodialisis del norte S.C.
Mexicali, 21100
Hospital Angeles Lindavista;Nefrologia
Mexico City, 07760
Hospital Star Medica Morelia
Morelia, 58070
Unidad De Dialisis La Loma S.C.
Pureto Vallarta, 48333
Hospital Regional De Alta Especialidad De Veracruz; Nephrology
Veracruz, 91700

Other trials in Mexico

About this study

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

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.

Conditions: Anemia, Kidney Disease, Chronic
Being tested: Methoxy polyethylene glycol-epoetin beta
Medical subject headings: Anemia, Kidney Diseases, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methoxy polyethylene glycol-epoetin betaDrug
Also called Mircera
Participants received 50-250 mcg SC according to local label

Study groups in NCT01519947
Study group	Role	What they receive
Pre-dialysis, sea level	Active comparator	Participants received 50-250 mcg SC according to local label. Receives: Drug: Methoxy polyethylene glycol-epoetin beta
Dialysis, sea level	Active comparator	Participants received 50-250 mcg SC according to local label. Receives: Drug: Methoxy polyethylene glycol-epoetin beta
Pre-dialysis, >1800 meters	Experimental	Participants received 50-250 mcg SC according to local label. Receives: Drug: Methoxy polyethylene glycol-epoetin beta
Dialysis, >1800 meters	Experimental	Participants received 50-250 mcg SC according to local label. Receives: Drug: Methoxy polyethylene glycol-epoetin beta

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
Measured: Up to approximately 20 months

Secondary outcomes (5)

Change in Hemoglobin Concentration
Measured: From baseline to 6 months
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
Measured: 3 and 6 months
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.
Measured: Up to approximately 20 months
Percentage of Participants Requiring Dose Adjustments
This outcome measure was not assessed.
Measured: Up to approximately 20 months
Incidence of Red Blood Cell Transfusions
This outcome measure was not assessed.
Measured: Up to approximately 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201230 May 2015

First posted27 Jan 2012 (estimated)
Study start30 May 2012
Primary completion30 May 2015
Study completion30 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anemia, Kidney Disease, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01519947
Sponsor's protocol ID: ML25754
Acronym: ALTITUD
Status last verified: Jun 2019
First submitted: 18 Jan 2012
Last updated: 19 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia, Kidney Disease, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01519947
Acronym / sponsor ID: ALTITUD / ML25754
Conditions: Anemia, Kidney Disease, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 30 May 2012 (actual)
Primary completion: 30 May 2015 (actual)
Study completion: 30 May 2015 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Posted 27 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Pre-dialysis, sea level	Active comparator	Drug: Methoxy polyethylene glycol-epoetin betaParticipants received 50-250 mcg SC according to local label.
Dialysis, sea level	Active comparator	Drug: Methoxy polyethylene glycol-epoetin betaParticipants received 50-250 mcg SC according to local label.
Pre-dialysis, >1800 meters	Experimental	Drug: Methoxy polyethylene glycol-epoetin betaParticipants received 50-250 mcg SC according to local label.
Dialysis, >1800 meters	Experimental	Drug: Methoxy polyethylene glycol-epoetin betaParticipants received 50-250 mcg SC according to local label.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methoxy polyethylene glycol-epoetin betaAlso: MirceraParticipants received 50-250 mcg SC according to local label	Drug	Dialysis, >1800 meters, Dialysis, sea level, Pre-dialysis, >1800 meters, Pre-dialysis, sea level

Primary outcome

Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL
Time frame: Up to approximately 20 months

5 secondary outcomes

Change in Hemoglobin Concentration
Time frame: From baseline to 6 months
Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment
Time frame: 3 and 6 months
Percentage of Participants With Adverse Events
Time frame: Up to approximately 20 months
Percentage of Participants Requiring Dose Adjustments
Time frame: Up to approximately 20 months
Incidence of Red Blood Cell Transfusions
Time frame: Up to approximately 20 months

Results and safety

Results posted to the registry on 27 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-dialysis, Sea Level	19	17
Dialysis, Sea Level	11	7
Pre-dialysis, >1800 Meters	15	8
Dialysis, >1800 Meters	42	34

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

Time frame: Up to approximately 20 months. Mean (Standard Deviation). Unit: micrograms (mcg)

Measure	Pre-dialysis, Sea Level n = 19	Dialysis, Sea Level n = 10	Pre-dialysis, >1800 Meters n = 15	Dialysis, >1800 Meters n = 42
Value	150.3 (69.0)	194.7 (214.2)	98.7 (22.5)	66.6 (33.6)

Population analysed: The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 20 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-dialysis, Sea Level	1 of 19 (5.3%)	16 of 19 (84.2%)	Not reported
Dialysis, Sea Level	3 of 10 (30%)	9 of 10 (90%)	Not reported
Pre-dialysis, >1800 Meters	2 of 15 (13.3%)	10 of 15 (66.7%)	Not reported
Dialysis, >1800 Meters	6 of 42 (14.3%)	36 of 42 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methoxy polyethylene glycol-epoetin beta in people with Anemia, Kidney Disease, Chronic, run by Hoffmann-La Roche at 7 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL (time frame: Up to approximately 20 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01519947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.