Chronic Renal DiseaseNCT01532297

Application of Citrate Dialysate in Chronic Haemodialysis

A study testing Citrate dialysate (CiDi) and Standard dialysate (StDi) in people with Chronic Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Renal Disease
What is being tested?: Citrate dialysate (CiDi) and Standard dialysate (StDi)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 4 sitesGermany
Study dates: Oct 2011to Aug 2013
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

signed informed consent
patients of either sex aged ≥ 18 years
stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
patients without planned or predictable changes within diet, anticoagulation and medication regimen

Who cannot join

pregnancy or lactation or woman in child bearing age without effective contraception
planned surgeries or hospital stay within the next 9 weeks
use of catheter as vascular access for dialysis
severe comorbidities not allowing to follow the study protocol
concomitant participation in another study
previous participation in this study

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

Märkische Dialysezentren GmbH
Lüdenscheid, 58509
Nephrologische Gemeinschaftspraxis
Lüdenscheid, 58509
Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin
Solingen, 42653
PHV Dialysezentrum
Wetzlar, 35578

Other trials in Germany

About this study

Read the detailed description

It is hypothesized that citrate dialysate may provide a local anticoagulation effect in the dialyser improving removal of uremic toxins. Study investigating the safety and efficacy of the citrate dialysis solution compared to standard acetate dialysis solution. Use of citrate dialysis solution is not associated with a clinically relevant development of adverse events.

Conditions: Chronic Renal Disease
Being tested: Citrate dialysate (CiDi), Standard dialysate (StDi)
Keywords: citrate dialysate, dialysis, calcium
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

Citrate dialysate (CiDi)Device
Use during chronic dialysis 3x/week
Standard dialysate (StDi)Device
Use during chronic dialysis 3x/week

Study groups in NCT01532297
Study group	Role	What they receive
HD treated with standard dialysate	Active comparator	Not described Receives: Device: Standard dialysate (StDi)
post-dilution oHDF with standard dialysate	Active comparator	Not described Receives: Device: Standard dialysate (StDi)
pre-dilution oHDF with citrate dialysate	Experimental	Not described Receives: Device: Citrate dialysate (CiDi)
HD treated with citrate dialysate	Experimental	Not described Receives: Device: Citrate dialysate (CiDi)
post-dilution oHDF with citrate dialysate	Experimental	Not described Receives: Device: Citrate dialysate (CiDi)
pre-dilution oHDF with standard dialysate	Active comparator	Not described Receives: Device: Standard dialysate (StDi)

What is being measured

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

Occurrence of clinically relevant calcium disturbances
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
Measured: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
during or post-dialysis severe alkalosis with pH ≥ 7.55
Measured: patients are followed for 8 weeks

Secondary outcomes (4)

Occurrence of clinically relevant acid-base disturbances
post-dialysis bicarbonate concentration ≥ 32 mmol/l
Measured: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
pre-treatment bicarbonate concentration ≥ 27 mmol/l
Measured: patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)
related to citrate dialysate
Measured: patients are followed for 8 weeks
Occurrence of clinically relevant adverse events
related to citrate
Measured: patients are followed for 8 weeks

Timeline

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

Oct 2011Aug 2013

First posted14 Feb 2012 (estimated)
Study startOct 2011
Primary completionApr 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Renal DiseaseStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532297
Sponsor's protocol ID: HD-CiDi-01-D
Other IDs: There is no secondary ID
Status last verified: Jun 2014
First submitted: 20 Oct 2011
Last updated: 6 Jun 2014
Results posted: No
Data monitoring committee: No

Publications

Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.
PubMed 37651553

Want to know more?

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 locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Application of Citrate Dialysate in Chronic Haemodialysis
ClinicalTrials.gov ID: NCT01532297
Acronym / sponsor ID: HD-CiDi-01-D
Conditions: Chronic Renal Disease
Keywords: citrate dialysate, dialysis, calcium
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Apr 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 14 Feb 2012 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
HD treated with standard dialysate	Active comparator	Device: Standard dialysate (StDi)
post-dilution oHDF with standard dialysate	Active comparator	Device: Standard dialysate (StDi)
pre-dilution oHDF with citrate dialysate	Experimental	Device: Citrate dialysate (CiDi)
HD treated with citrate dialysate	Experimental	Device: Citrate dialysate (CiDi)
post-dilution oHDF with citrate dialysate	Experimental	Device: Citrate dialysate (CiDi)
pre-dilution oHDF with standard dialysate	Active comparator	Device: Standard dialysate (StDi)

Who may qualify

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

Key inclusion criteria (4 listed)

signed informed consent
patients of either sex aged ≥ 18 years
stable chronic dialysis patients undergoing a 3x/week high-flux dialysis for at least three months
patients without planned or predictable changes within diet, anticoagulation and medication regimen

Key exclusion criteria (6 listed)

pregnancy or lactation or woman in child bearing age without effective contraception
planned surgeries or hospital stay within the next 9 weeks
use of catheter as vascular access for dialysis
severe comorbidities not allowing to follow the study protocol
concomitant participation in another study

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
Citrate dialysate (CiDi)Use during chronic dialysis 3x/week	Device	HD treated with citrate dialysate, post-dilution oHDF with citrate dialysate, pre-dilution oHDF with citrate dialysate
Standard dialysate (StDi)Use during chronic dialysis 3x/week	Device	HD treated with standard dialysate, post-dilution oHDF with standard dialysate, pre-dilution oHDF with standard dialysate

Primary outcome

Occurrence of clinically relevant calcium disturbances
Time frame: patients are followed for 8 weeks
during or post-dialysis hypocalcaemia with ionized Ca ≤ 0.9 mmol/l
Occurrence of clinically relevant acid-base disturbances
Time frame: patients are followed for 8 weeks
during or post-dialysis severe alkalosis with pH ≥ 7.55

4 secondary outcomes

Occurrence of clinically relevant acid-base disturbances
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant acid-base disturbances
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant intradialytic complications (adverse events)
Time frame: patients are followed for 8 weeks
Occurrence of clinically relevant adverse events
Time frame: patients are followed for 8 weeks

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 6 Jun 2014.
Derived from this study: PubMed 37651553Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

Related trials for Chronic Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
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Chronic Kidney Diseases

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.

Michael Schmitz, Dr. principal investigator

Städt. Klinikum Solingen gemeinnützige GmbH Klinik für Nephrologie und Allgemeine Innere Medizin

Olaf Loke, Dr. principal investigator

Nephrologische Gemeinschaftspraxis

Klaus Kalb, Dr. principal investigator

Märkische Dialysezentren GmbH

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

Questions about this trial

What is this clinical trial studying?

A study testing Citrate dialysate (CiDi) and Standard dialysate (StDi) in people with Chronic Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 4 sites in Germany.

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 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: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. 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?

Occurrence of clinically relevant calcium disturbances (time frame: patients are followed for 8 weeks). The study lists 2 primary outcomes in all. 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 NCT01532297, which also lists 1 linked publication.

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 6 Jun 2014.