AnemiaPhase 3NCT00399269
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
A Phase 3 study testing Recombinant Human Erythropoietin alpha in people with Anemia, run by Cadila Pharnmaceuticals at 1 site in India.
Trial summary
To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anemia
- What is being tested?
- Recombinant Human Erythropoietin alpha
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 to 70 yrs of age of either sex.
- CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.
- Patients who are willing to give the consent
- Patient with Anemia of Chronic Renal Failure with Hb < 10.
Who cannot join
- Patients who are known hypersensitive to rHu-EPO.
- Patient's with history of anemia due to causes other than anemia of CRF.
- Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.
- Patient's with history of G.I. bleeding (Overt or Occult).
- Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.
- Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.
- Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.
- Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.
To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.
Read the detailed description
Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.
In normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.
- Conditions
- Anemia
- Being tested
- Recombinant Human Erythropoietin alpha
- Keywords
- Anemia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Erythropoietin alphaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
OR
Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
Secondary outcomes (1)
Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startDec 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cadila Pharnmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. H. L. Trivedi, MD, Principal investigator, IKDRC, Civil Hospital, AhmedabadDr. Pankaj Shah, Nephrologist, Principal investigator, IKDRC, Civil Hospital, AhmedabadDr. Shishir Gang, Nephrologist, Principal investigator, Muljibhai Patel Urological HospitalDr. Himanshu Patel, Nephrologist, Principal investigator, Gujarat Kidney Foundation, AhmedabadDr. Miten Mehta, Nephrologist, Principal investigator, Anandabawa Kidney Dialysis Center, JamnagarDr. Asit Mehta, Nephrologist, Principal investigator, Apollo Hospitals, Ahmedabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399269
- Sponsor's protocol ID
- CR - 50/9180
- Status last verified
- Jun 2009
- First submitted
- 12 Nov 2006
- Last updated
- 11 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.
- ClinicalTrials.gov ID
- NCT00399269
- Acronym / sponsor ID
- CR - 50/9180
- Conditions
- Anemia
- Keywords
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cadila PharnmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.
Detailed description
Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.
In normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 to 70 yrs of age of either sex.
- CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.
- Patients who are willing to give the consent
- Patient with Anemia of Chronic Renal Failure with Hb < 10.
Key exclusion criteria (8 listed)
- Patients who are known hypersensitive to rHu-EPO.
- Patient's with history of anemia due to causes other than anemia of CRF.
- Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.
- Patient's with history of G.I. bleeding (Overt or Occult).
- Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.
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 |
|---|---|---|
| Recombinant Human Erythropoietin alpha | Drug | – |
Primary outcome
Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
OR
Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
1 secondary outcome
Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2009.
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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.
Dr. H. L. Trivedi, MD principal investigator
IKDRC, Civil Hospital, Ahmedabad
Dr. Pankaj Shah, Nephrologist principal investigator
IKDRC, Civil Hospital, Ahmedabad
Dr. Shishir Gang, Nephrologist principal investigator
Muljibhai Patel Urological Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Human Erythropoietin alpha in people with Anemia, run by Cadila Pharnmaceuticals at 1 site in India.
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 4 inclusion and 8 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 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2009.