Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517413
First received: August 16, 2007
Last updated: March 29, 2016
Last verified: March 2016
Results First Received: February 24, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anemia
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 261 participants were screened and 163 participants were enrolled from 26 centers in 9 countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay, Venezuela) from 08 October 2007 to 15 May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
C.E.R.A Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.

Participant Flow:   Overall Study
    C.E.R.A
STARTED   163 
COMPLETED   102 
NOT COMPLETED   61 
Adverse Event                7 
Death                13 
Protocol Violation                15 
Withdrawal by Subject                2 
Failure to return                1 
Other-Reasons                23 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intention To Treat (ITT) population included participants who received at least 1 dose of C.E.R.A. (Week 0) and for whom data for at least one follow-up variable were available.

Reporting Groups
  Description
C.E.R.A Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.

Baseline Measures
   C.E.R.A 
Overall Participants Analyzed 
[Units: Participants]
 161 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.7  (14.95) 
Gender 
[Units: Participants]
 
Female   67 
Male   94 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Maintaining Their Mean Hb Concentration Within ±1.0 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter   [ Time Frame: EEP (Week 16 to 24) ]

2.  Secondary:   Mean Change in the Hb Concentration Between the Stability Verification Period and the EEP   [ Time Frame: SVP (Week -4 to -1), EEP (Week 16 to 24) ]

3.  Secondary:   Percentage of Participants Maintaining Hb Concentration Within The Target Range 10.5 and 12.5 g/dL Throughout the EEP   [ Time Frame: EEP (Week 16 to 24) ]

4.  Secondary:   Mean Time Spent by the Participants in the Hb Target Range 10.5-12.5 g/dL During EEP   [ Time Frame: EEP (Week 16 to 24) ]

5.  Secondary:   Mean C.E.R.A Dose To Maintain Hb Level Within the Range 10.5-12.5 g/dL Throughout the EEP   [ Time Frame: EEP (Week 16 to 24) ]

6.  Secondary:   Percentage of Participants Requiring Dose Adjustments of C.E.R.A During the DTP and EEP   [ Time Frame: Baseline (Week 0) to Week 24 ]

7.  Secondary:   Mean Monthly Dose of C.E.R.A During the DTP and EEP   [ Time Frame: Baseline (Week 0) to Week 24 ]

8.  Secondary:   Incidence of Red Blood Cell Transfusions During the C.E.R.A. Treatment Phase   [ Time Frame: Baseline (Week 0) to Week 44 ]

9.  Secondary:   Number of Participants With Adverse Events and Serious Adverse Events   [ Time Frame: Up to Week 52 ]

10.  Secondary:   Mean Haemoglobin Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 ]

11.  Secondary:   Mean Hematocrit Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 ]

12.  Secondary:   Mean White Blood Cells and Thrombocyte Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]

13.  Secondary:   Mean Phosphate and Potassium Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]

14.  Secondary:   Mean Creatinine, Iron, and Total Iron Binding Capacity Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]

15.  Secondary:   Mean Transferrin Saturation Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]

16.  Secondary:   Mean Albumin and Transferrin Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]

17.  Secondary:   Mean C-Reactive Protein Levels Over Time   [ Time Frame: Baseline (Week 0), 8, 16, 24, 32, 40, and 48 ]

18.  Secondary:   Mean Ferritin Levels Over Time   [ Time Frame: Baseline (Week 0), Week 8, 16, 24, 32, 40, and 48 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517413     History of Changes
Other Study ID Numbers: ML20881
Study First Received: August 16, 2007
Results First Received: February 24, 2016
Last Updated: March 29, 2016
Health Authority: Ecuador: Ministry of Health