A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

NCT01066000 | Terminated Phase 4 Results

• 1 other identifier: ML21736
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 12

Brief Summary

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)

  The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not \>12 g/dL and not \< 10 g/dL.

  Up to Week 24

Secondary Outcomes (7)

• Number of Participants With Adverse Events and Serious Adverse Events

  Up to Week 28

• Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period

  Up to Week 24

• Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period

  Up to Week 24

• Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period

  Up to Week 24

• Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods

  Up to Week 24

Study Arms (1)

Mircera

EXPERIMENTAL

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Interventions

methoxy polyethylene glycol-epoetin beta [Mircera] DRUG

initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

Mircera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>/=18 years of age
• Chronic renal anaemia
• Haemoglobin concentration between 10 and 12 g/dL at screening
• Adequate iron status
• Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
• Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

You may not qualify if:

• Change in haemoglobin concentration \>/=2 g/dL during screening
• Transfusion of red blood cells less than 8 weeks prior to screening
• Poorly controlled hypertension
• Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
• Active malignant disease
• Haemolysis
• Haemoglobinopathies

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Advent Hospital; Kidney and Hipertension

Bandung, 40131, Indonesia

Location

Sanglah Hospital; Kidney and Hipertension

Denpasar, 80114, Indonesia

Location

Rumah Sakit Pgi Cikini; Renal & Hypertension

Jakarta, 10330, Indonesia

Location

Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department

Jakarta, 10440, Indonesia

Location

Pelni Hospital; Kidney and Hipertension

Jakarta, 11410, Indonesia

Location

Pondok Indah Hospital; Kidney and Hipertension

Jakarta, 12310, Indonesia

Location

Pantai Indah Kapuk Hospital; Kidney and Hipertension

Jakarta, 14460, Indonesia

Location

Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension

Medan, 20119, Indonesia

Location

Pirngadi; Renal and Hypertension

Medan, 20234, Indonesia

Location

Telogorejo Hospital; Renal and Hypertension

Semarang, 50136, Indonesia

Location

Dokter Soetomo Hospital

Surabaya, 60286, Indonesia

Location

PHC Hospital; Renal and Hypertension

Surabaya, 60286, Indonesia

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Limitations and Caveats

This was an open-label, single arm study with no control arms for comparison of results from this study. The study was prematurely terminated due to high screening failures and low recruitment rate. Therefore, the data only showed a trend.

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: October 31, 2009
• Primary Completion: September 30, 2011
• Study Completion: September 30, 2011
• Last Updated: November 13, 2017
• Results First Posted: May 13, 2016

Record last verified: 2017-11

Locations

ID (12)