AnemiaNCT07889102
Impact of Telepharmacy on Hemodialysis Outcomes
A study testing Telepharmacy Intervention in people with Anemia and Hemodialysis, run by Damanhour University at 2 sites in Egypt.
Trial summary
This study looked at whether regular follow-up by pharmacists through phone calls (telepharmacy) can help improve the treatment of anaemia in patients undergoing haemodialysis. Anaemia is very common in patients with kidney disease and can cause fatigue, weakness, and an increased risk of heart problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Hemodialysis
- What is being tested?
- Telepharmacy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 30 Apr 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Confirmed diagnosis of chronic kidney disease (CKD).
- Receiving maintenance hemodialysis at one of the participating centers.
- Receiving regular hemodialysis sessions.
- Anemia requiring treatment with erythropoiesis-stimulating agents (ESAs).
- Baseline hemoglobin level <11.5 g/dL.
Show all 9Show fewer
- Able to communicate by telephone to participate in the telepharmacy intervention.
- Willing and able to provide written informed consent.
- Willing to comply with all study procedures and follow-up assessments.
Who cannot join
- Unwilling or unable to provide informed consent.
- Significant cognitive impairment or psychiatric illness that could interfere with study participation.
- No reliable telephone access for telepharmacy follow-up.
- Unstable clinical condition requiring emergency or intensive care.
- Severe comorbid conditions expected to limit short-term survival.
- Not receiving regular maintenance hemodialysis.
- Incomplete baseline clinical or laboratory data.
- Inability or unwillingness to complete the planned follow-up period
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Menoufia University Hospital
Shibīn al Kawm, Menofia, 32511
Menoufia University Hospital
Shibīn al Kawm, Menoufia, 32511
About this study
Official title: Effect of Telepharmacy on Clinical and Economic Outcomes in Hemodialysis Patients: A Randomized Controlled Trial
This study looked at whether regular follow-up by pharmacists through phone calls (telepharmacy) can help improve the treatment of anaemia in patients undergoing haemodialysis.
Anaemia is very common in patients with kidney disease and can cause fatigue, weakness, and an increased risk of heart problems. It is usually treated with medications such as erythropoietin (EPO), but managing the correct dose and ensuring patients follow treatment can be challenging. In this study, patients were divided into two groups. One group received standard care, while the other group received additional support from pharmacists through regular phone calls. During these calls, pharmacists helped patients understand their medications, encouraged adherence, monitored symptoms, and worked with doctors to adjust treatment when needed.
- Conditions
- Anemia, Hemodialysis
- Being tested
- Routine Standard Care, Telepharmacy Intervention
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Standard CareOther
Participants assigned to the Routine Standard Care intervention received routine maintenance hemodialysis care according to the participating hospitals' standard clinical practice. Standard care included regular nephrologist follow-up, routine laboratory monitoring (including hemoglobin and other relevant biochemical parameters), prescription and adjustment of erythropoiesis-stimulating agents (ESAs) and other medications as clinically indicated, and conventional nursing and dialysis care. Medication management and treatment decisions were made during routine clinical visits. Unlike the experimental arm, participants did not receive the structured telepharmacy intervention, including scheduled telephone consultations, proactive medication review, adherence counseling, pharmacist-initiated remote monitoring, or pharmacist-led therapeutic follow-up.
Telepharmacy InterventionBehavioural
Pharmacist-led remote care including scheduled telephone follow-up, medication review, adherence assessment, individualized counseling, monitoring of laboratory results, identification and resolution of drug-related problems, and collaboration with physicians to optimize erythropoiesis-stimulating agent (ESA) therapy and overall medication management. Participants continued to receive routine standard care throughout the study in addition to the telepharmacy intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Control Group | Active comparator | Participants assigned to this arm received routine hemodialysis care according to standard clinical practice without additional telepharmacy support. This included regular physician follow-up, laboratory monitoring, and medication management as determined by the treating healthcare team. No structured pharmacist-led remote monitoring or scheduled telecommunication-based interventions were provided. Receives: Other: Routine Standard Care |
| Telepharmacy Intervention Group | Experimental | Participants assigned to this arm received routine maintenance hemodialysis care in addition to a structured telepharmacy intervention delivered by trained clinical pharmacists over a 5-month period. The intervention included scheduled telephone follow-up, medication review, adherence assessment, individualized counseling, monitoring of laboratory results, identification and resolution of drug-related problems, and collaboration with treating physicians to optimize erythropoiesis-stimulating agent (ESA) therapy and overall medication management. Receives: Other: Routine Standard Care; Behavioral: Telepharmacy Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin (Hb) level
Measured: 5 months
Secondary outcomes (1)
Change in erythropoietin dose
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Dec 2024
- Primary completion1 Apr 2025
- Study completion30 Apr 2025
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was designed as an interventional randomized controlled study, meaning that patients were actively assigned to different types of care to compare outcomes. Participants were randomly divided into two groups (1:1 allocation). One group received standard care, while the other group received additional telepharmacy support. This support included regular scheduled phone calls with clinical pharmacists, medication review, adherence monitoring, and personalized counseling. The study followed a parallel-group model, meaning both groups were treated at the same time but received different levels of care. Patients were followed over a period of five months, and outcomes such as hemoglobin levels, medication use, treatment costs, and safety events were measured and compared between groups.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889102
- Sponsor's protocol ID
- 12/2024 INTM11
- Status last verified
- May 2024
- First submitted
- 22 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telepharmacy on Clinical and Economic Outcomes in Hemodialysis Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07889102
- Acronym / sponsor ID
- 12/2024 INTM11
- Conditions
- Anemia, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 22 Oct 2026 (actual)
- 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.
This study looked at whether regular follow-up by pharmacists through phone calls (telepharmacy) can help improve the treatment of anaemia in patients undergoing haemodialysis.
Anaemia is very common in patients with kidney disease and can cause fatigue, weakness, and an increased risk of heart problems. It is usually treated with medications such as erythropoietin (EPO), but managing the correct dose and ensuring patients follow treatment can be challenging. In this study, patients were divided into two groups. One group received standard care, while the other group received additional support from pharmacists through regular phone calls. During these calls, pharmacists helped patients understand their medications, encouraged adherence, monitored symptoms, and worked with doctors to adjust treatment when needed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as an interventional randomized controlled study, meaning that patients were actively assigned to different types of care to compare outcomes. Participants were randomly divided into two groups (1:1 allocation). One group received standard care, while the other group received additional telepharmacy support. This support included regular scheduled phone calls with clinical pharmacists, medication review, adherence monitoring, and personalized counseling. The study followed a parallel-group model, meaning both groups were treated at the same time but received different levels of care. Patients were followed over a period of five months, and outcomes such as hemoglobin levels, medication use, treatment costs, and safety events were measured and compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Control Group | Active comparator | Other: Routine Standard CareParticipants assigned to this arm received routine hemodialysis care according to standard clinical practice without additional telepharmacy support. This included regular physician follow-up, laboratory monitoring, and medication management as determined by the treating healthcare team. No structured pharmacist-led remote monitoring or scheduled telecommunication-based interventions were provided. |
| Telepharmacy Intervention Group | Experimental | Other: Routine Standard Care, Behavioral: Telepharmacy InterventionParticipants assigned to this arm received routine maintenance hemodialysis care in addition to a structured telepharmacy intervention delivered by trained clinical pharmacists over a 5-month period. The intervention included scheduled telephone follow-up, medication review, adherence assessment, individualized counseling, monitoring of laboratory results, identification and resolution of drug-related problems, and collaboration with treating physicians to optimize erythropoiesis-stimulating agent (ESA) therapy and overall medication management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults aged 18 years or older.
- Confirmed diagnosis of chronic kidney disease (CKD).
- Receiving maintenance hemodialysis at one of the participating centers.
- Receiving regular hemodialysis sessions.
- Anemia requiring treatment with erythropoiesis-stimulating agents (ESAs).
Key exclusion criteria (8 listed)
- Unwilling or unable to provide informed consent.
- Significant cognitive impairment or psychiatric illness that could interfere with study participation.
- No reliable telephone access for telepharmacy follow-up.
- Unstable clinical condition requiring emergency or intensive care.
- Severe comorbid conditions expected to limit short-term survival.
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 |
|---|---|---|
| Routine Standard CareParticipants assigned to the Routine Standard Care intervention received routine maintenance hemodialysis care according to the participating hospitals' standard clinical practice. Standard care included regular nephrologist follow-up, routine laboratory monitoring (including hemoglobin and other relevant biochemical parameters), prescription and adjustment of erythropoiesis-stimulating agents (ESAs) and other medications as clinically indicated, and conventional nursing and dialysis care. Medication management and treatment decisions were made during routine clinical visits. Unlike the experimental arm, participants did not receive the structured telepharmacy intervention, including scheduled telephone consultations, proactive medication review, adherence counseling, pharmacist-initiated remote monitoring, or pharmacist-led therapeutic follow-up. | Other | Standard Care Control Group, Telepharmacy Intervention Group |
| Telepharmacy InterventionPharmacist-led remote care including scheduled telephone follow-up, medication review, adherence assessment, individualized counseling, monitoring of laboratory results, identification and resolution of drug-related problems, and collaboration with physicians to optimize erythropoiesis-stimulating agent (ESA) therapy and overall medication management. Participants continued to receive routine standard care throughout the study in addition to the telepharmacy intervention. | Behavioural | Telepharmacy Intervention Group |
Primary outcome
Change in hemoglobin (Hb) level
Time frame: 5 months
1 secondary outcome
Change in erythropoietin dose
Time frame: 5 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 22 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepharmacy Intervention in people with Anemia and Hemodialysis, run by Damanhour University at 2 sites in Egypt.
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 9 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Change in hemoglobin (Hb) level (time frame: 5 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 22 Oct 2026.