Anemia, Diabetes, Kidney Disease, Chronic, HypertensionNCT02444845
Study of Anemia in Chronic Kidney Disease (CKD) Among High-Risk Hypertensive and Diabetic Patients in Pakistan
An observational study of Anemia, Diabetes, Kidney Disease, Chronic, Hypertension, run by Hoffmann-La Roche at 3 sites in Pakistan.
Trial summary
The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anemia, Diabetes, Kidney Disease, Chronic, Hypertension
- How many people
- 246 participants
- Where
- 3 sitesPakistan
- Study dates
- May 2011to Aug 2012
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll high-risk hypertensive and/or diabetic patients in Pakistan who meet eligibility criteria for observation.
Who may be able to join
- Age greater than or equal to 40 years
- Known hypertension and/or diabetes for at least 3 years
- Positive dipstick test result for proteinuria
Who cannot join
- Known CKD
- Receiving erythropoietin
- Blood transfusion within 8 weeks
- History of acute or chronic bleeding, hemolysis, or hemoglobinopathy
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Prevalence of Anaemia Secondary to Early Stage Chronic Kidney Disease in High Risk Diabetic and/or Hypertensive Population
The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.
- Medical subject headings
- Anemia, Diabetes Mellitus, Kidney Diseases, Bronchiolitis Obliterans Syndrome, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Hypertensive and diabetic patients who meet eligibility criteria will be enrolled and evaluated for the presence of anemia secondary to CKD. The first visit will capture medical history including risk factors for CKD; laboratory assessments will be performed at the second and third visits to evaluate glomerular filtration rate (eGFR) and anemia profile, respectively. Participants who are not diagnosted with CKD based upon the second visit will not return for the third visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with anemia secondary to CKD
Measured: Up to 12 months
Secondary outcomes (1)
Use of treatment modalities for the management of anemia secondary to CKD
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Diabetes, Kidney Disease, Chronic, HypertensionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444845
- Sponsor's protocol ID
- ML27762
- Status last verified
- Mar 2018
- First submitted
- 12 May 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anaemia Secondary to Early Stage Chronic Kidney Disease in High Risk Diabetic and/or Hypertensive Population
- ClinicalTrials.gov ID
- NCT02444845
- Acronym / sponsor ID
- ML27762
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 15 May 2015 (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.
The purpose of this study is to evaluate the prevalence of CKD-related anemia at an early stage through screening of high-risk patients in Pakistan at the level of physicians, cardiologists, and diabetologists. The information gathered may serve as a foundation in formulating national guidelines for better early diagnosis and management of patients with CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Hypertensive and diabetic patients who meet eligibility criteria will be enrolled and evaluated for the presence of anemia secondary to CKD. The first visit will capture medical history including risk factors for CKD; laboratory assessments will be performed at the second and third visits to evaluate glomerular filtration rate (eGFR) and anemia profile, respectively. Participants who are not diagnosted with CKD based upon the second visit will not return for the third visit. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll high-risk hypertensive and/or diabetic patients in Pakistan who meet eligibility criteria for observation.
Key inclusion criteria (3 listed)
- Age greater than or equal to 40 years
- Known hypertension and/or diabetes for at least 3 years
- Positive dipstick test result for proteinuria
Key exclusion criteria (4 listed)
- Known CKD
- Receiving erythropoietin
- Blood transfusion within 8 weeks
- History of acute or chronic bleeding, hemolysis, or hemoglobinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with anemia secondary to CKD
Time frame: Up to 12 months
1 secondary outcome
Use of treatment modalities for the management of anemia secondary to CKD
Time frame: Up to 12 months
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 20 Mar 2018.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, Diabetes, Kidney Disease, Chronic, Hypertension, run by Hoffmann-La Roche at 3 sites in Pakistan.
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 3 inclusion and 4 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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.
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?
Number of patients with anemia secondary to CKD (time frame: Up to 12 months). 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 20 Mar 2018.