End-Stage Kidney Disease (ESKD)NCT07662889

Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

A study testing Conventional Hemodialysis and Hemodiafiltration in people with End-Stage Kidney Disease (ESKD) and Chronic Kidney Disease (CKD), run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: End-Stage Kidney Disease (ESKD), Chronic Kidney Disease (CKD)
What is being tested?: Conventional Hemodialysis and Hemodiafiltration
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 sitePakistan
Study dates: 23 May 2026to 22 Nov 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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

Adult patients aged 18-70 years.
Both male or female.
End-stage kidney disease as per operational definition.
On a stable dialysis prescription for at least 3 months, with thrice-weekly sessions (or unit-standard schedule) and stable dry weight assessment.
Clinically stable over the preceding 4 weeks, with no hospitalization or acute intercurrent illness.

Who cannot join

Cardiovascular instability: recurrent intradialytic hypotension (≥30% of sessions in the prior month requiring saline or early termination), uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg despite therapy), recent acute coronary syndrome, stroke, or decompensated heart failure within 3 months.
Advanced hepatic disease (decompensated cirrhosis or refractory ascites), active systemic infection, chronic inflammatory disease flare, or active malignancy under treatment likely to confound fluid status or survival.
Recent blood transfusion within the preceding 4 weeks, or active bleeding, as these may distort hemoglobin and inflammatory indices.
Advanced chronic liver disease, nephrotic-range protein loss, or other conditions likely to substantially alter serum albumin independent of dialysis modality.
Parathyroidectomy history or current use of intravenous calcimimetics initiation/change within the preceding 4 weeks, if expected to markedly alter intact parathyroid hormone.
Adherence concerns: documented inability to follow fluid/salt advice or to attend scheduled treatments during the screening period; anticipated surgery or hospitalization within the study window.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site

Services Institute of Medical Sciences, Lahore
Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: A Randomized Clinical Trial Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters

Chronic kidney disease may progress to end-stage renal disease, a stage in which the kidneys will no longer be able to adequately remove extra fluid and waste products from the body. Many patients with end-stage renal disease will require regular dialysis to survive. Conventional hemodialysis is the most commonly used dialysis technique and will mainly remove waste products through diffusion. Hemodiafiltration is another dialysis technique that will combine diffusion with convection and may help remove a wider range of waste substances from the blood.

This randomized clinical trial will compare hemodiafiltration with conventional hemodialysis in adult patients with end-stage renal disease who are already receiving maintenance dialysis. Eligible participants will be assigned by random allocation to either conventional hemodialysis or hemodiafiltration. Both treatments will be provided as part of routine dialysis care, and no experimental drug will be used.

The main purpose of the study will be to determine whether hemodiafiltration will lead to better fluid control compared with conventional hemodialysis. Fluid control will be assessed by measuring the average weight gained between dialysis sessions over a four-week period. The study will also compare selected blood test parameters between the two groups after one month, including hemoglobin, C-reactive protein, serum albumin, total cholesterol, serum calcium, serum phosphate, and intact parathyroid hormone.

Conditions: End-Stage Kidney Disease (ESKD), Chronic Kidney Disease (CKD)
Being tested: Conventional Hemodialysis, Hemodiafiltration
Keywords: Hemodiafiltration, Conventional Hemodialysis, Maintenance Hemodialysis, End-Stage Renal Disease
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Conventional HemodialysisOther
Conventional bicarbonate hemodialysis will be performed as part of routine maintenance dialysis care. This technique will primarily remove solutes through diffusion across a semipermeable dialysis membrane, with ultrafiltration for fluid removal.
HemodiafiltrationOther
Hemodiafiltration will be performed as part of routine maintenance dialysis care. This technique will combine diffusive and convective solute removal, using replacement fluid according to departmental protocol.

Study groups in NCT07662889
Study group	Role	What they receive
Group A Conventional Hemodialysis	Active comparator	Participants assigned to this group will receive conventional bicarbonate hemodialysis as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up. Receives: Other: Conventional Hemodialysis
Group B Hemodiafiltration	Experimental	Participants assigned to this group will receive hemodiafiltration as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up. Receives: Other: Hemodiafiltration

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Interdialytic Weight Gain
Mean interdialytic weight gain will be assessed in kilograms. For each dialysis session, interdialytic weight gain will be calculated as the pre-dialysis weight of the current session minus the post-dialysis weight of the immediately preceding session. Body weight will be measured using a calibrated digital scale in the dialysis unit. Session-level interdialytic weight gain values will be recorded throughout the follow-up period, and the mean value for each participant will be calculated by dividing the total interdialytic weight gain by the number of attended dialysis sessions.
Measured: Baseline and one month after randomization.

Secondary outcomes (7)

Mean Hemoglobin Level
Hemoglobin level will be measured in g/dL using routine hospital laboratory testing. The mean hemoglobin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean C-Reactive Protein Level
C-reactive protein level will be measured in mg/L using routine hospital laboratory testing. The mean C-reactive protein level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean Serum Albumin Level
Serum albumin level will be measured in g/dL using routine hospital laboratory testing. The mean serum albumin level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean Total Cholesterol Level
Total cholesterol level will be measured in mg/dL using routine hospital laboratory testing. The mean total cholesterol level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean Serum Calcium Level
Total serum calcium level will be measured in mg/dL using routine hospital laboratory testing. The mean serum calcium level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean Serum Phosphate Level
Serum phosphate level will be measured in mg/dL using routine hospital laboratory testing. The mean serum phosphate level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.
Mean Intact Parathyroid Hormone Level
Intact parathyroid hormone level will be measured in pg/mL using routine hospital laboratory testing. The mean intact parathyroid hormone level will be compared between the hemodiafiltration and conventional hemodialysis groups at one month, with baseline measurement recorded for within-group change assessment.
Measured: Baseline and one month after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202622 Nov 2026

First posted23 Jun 2026
Study start23 May 2026
Primary completion22 Nov 2026 (estimated)
Study completion22 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for End-Stage Kidney Disease (ESKD)Studies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07662889
Sponsor's protocol ID: ServicesIMSP2
Status last verified: Jun 2026
First submitted: 10 Jun 2026
Last updated: 23 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial Comparing Hemodiafiltration to Conventional Hemodialysis: Effects on Clinical and Biochemical Parameters
ClinicalTrials.gov ID: NCT07662889
Acronym / sponsor ID: ServicesIMSP2
Conditions: End-Stage Kidney Disease (ESKD), Chronic Kidney Disease (CKD)
Keywords: Hemodiafiltration, Conventional Hemodialysis, Maintenance Hemodialysis, End-Stage Renal Disease
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 64 participants (estimated)
Lead sponsor: Services Institute of Medical Sciences, PakistanOther government
Study start: 23 May 2026 (actual)
Primary completion: 22 Nov 2026 (estimated)
Study completion: 22 Nov 2026 (estimated)
First posted: 23 Jun 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A Conventional Hemodialysis	Active comparator	Other: Conventional HemodialysisParticipants assigned to this group will receive conventional bicarbonate hemodialysis as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.
Group B Hemodiafiltration	Experimental	Other: HemodiafiltrationParticipants assigned to this group will receive hemodiafiltration as per routine departmental dialysis protocol. Each dialysis session will last at least four hours and will be delivered twice or thrice weekly according to unit practice. Other dialysis prescription parameters will be kept as consistent as clinically feasible during follow-up.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Adult patients aged 18-70 years.
Both male or female.
End-stage kidney disease as per operational definition.
On a stable dialysis prescription for at least 3 months, with thrice-weekly sessions (or unit-standard schedule) and stable dry weight assessment.
Clinically stable over the preceding 4 weeks, with no hospitalization or acute intercurrent illness.

Key exclusion criteria (6 listed)

Cardiovascular instability: recurrent intradialytic hypotension (≥30% of sessions in the prior month requiring saline or early termination), uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg despite therapy), recent acute coronary syndrome, stroke, or decompensated heart failure within 3 months.
Advanced hepatic disease (decompensated cirrhosis or refractory ascites), active systemic infection, chronic inflammatory disease flare, or active malignancy under treatment likely to confound fluid status or survival.
Recent blood transfusion within the preceding 4 weeks, or active bleeding, as these may distort hemoglobin and inflammatory indices.
Advanced chronic liver disease, nephrotic-range protein loss, or other conditions likely to substantially alter serum albumin independent of dialysis modality.
Parathyroidectomy history or current use of intravenous calcimimetics initiation/change within the preceding 4 weeks, if expected to markedly alter intact parathyroid hormone.

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
Conventional HemodialysisConventional bicarbonate hemodialysis will be performed as part of routine maintenance dialysis care. This technique will primarily remove solutes through diffusion across a semipermeable dialysis membrane, with ultrafiltration for fluid removal.	Other	Group A Conventional Hemodialysis
HemodiafiltrationHemodiafiltration will be performed as part of routine maintenance dialysis care. This technique will combine diffusive and convective solute removal, using replacement fluid according to departmental protocol.	Other	Group B Hemodiafiltration

Primary outcome

Mean Interdialytic Weight Gain
Time frame: Baseline and one month after randomization.
Mean interdialytic weight gain will be assessed in kilograms. For each dialysis session, interdialytic weight gain will be calculated as the pre-dialysis weight of the current session minus the post-dialysis weight of the immediately preceding session. Body weight will be measured using a calibrated digital scale in the dialysis unit. Session-level interdialytic weight gain values will be recorded throughout the follow-up period, and the mean value for each participant will be calculated by dividing the total interdialytic weight gain by the number of attended dialysis sessions.

7 secondary outcomes

Mean Hemoglobin Level
Time frame: Baseline and one month after randomization.
Mean C-Reactive Protein Level
Time frame: Baseline and one month after randomization.
Mean Serum Albumin Level
Time frame: Baseline and one month after randomization.
Mean Total Cholesterol Level
Time frame: Baseline and one month after randomization.
Mean Serum Calcium Level
Time frame: Baseline and one month after randomization.
Mean Serum Phosphate Level
Time frame: Baseline and one month after randomization.
Mean Intact Parathyroid Hormone Level
Time frame: Baseline and one month after randomization.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.

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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.

Zara Ramzan principal investigator

Services Institute of Medical Sciences, Pakistan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. 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 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?

This study is still under way. Results are not available in the source record yet.

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?

Mean Interdialytic Weight Gain (time frame: Baseline and one month after randomization.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662889.

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 23 Jun 2026.