Renal Insufficiency, ChronicPhase 2/3NCT03577249
Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
A Phase 2/3 study testing Dialysis Solutions in people with Renal Insufficiency, Chronic and Inflammation, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Inflammation
- What is being tested?
- Dialysis Solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2014to 30 Jul 2015
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years
- creatinine clearance <5ml/min
- treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
- treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy
Who cannot join
- known neoplastic disease
- active chronic inflammatory disease
- active acute inflammatory disease
Trial locations and contacts
1 site in 1 country.
Italy1 site
Città della Salute e Della Scienza di Torino - Presidi CTO e Molinette
Torino, To, 10126
About this study
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.
- Conditions
- Renal Insufficiency, Chronic, Inflammation
- Being tested
- Dialysis Solutions
- Medical subject headings
- Renal Insufficiency, Chronic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysis SolutionsDrug
Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Drug: Dialysis Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum CRP (C-reactive protein)
Change in serum CRP during the 3 months of citrate-buffered dialysis
Measured: Months 4th to 6th
Secondary outcomes (2)
Change in dialysis efficiency
Dougirdas formula will be used to estimate dialysis efficiency at the beginning and completion of each study interval
Measured: Every 3 months (month 0, 6, 3 and completion - 9)
Change in serum CRP (C-reactive protein)
Variation of serum CRP at the beginning and completion of each study interval
Measured: Every 3 months (month 0, 6, 3 and completion - 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start30 Oct 2014
- Primary completion30 Jul 2015
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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 2/3
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Model description
- 45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Cantaluppi, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577249
- Sponsor's protocol ID
- 0064476
- Other IDs
- 2CEI-753
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2018
- Last updated
- 9 Jul 2018
- 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 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Effects of Citrate-buffered Solutions on Dialysis Efficiency and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT03577249
- Acronym / sponsor ID
- 0064476
- Conditions
- Renal Insufficiency, Chronic, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 30 Jul 2015 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 5 Jul 2018 (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.
In this study 45 patients undergoing weekly dialysis for chronic end stage renal disease will be enrolled. The patients will be treated with a standard dialysis solution, containing acetate buffer, for 3 months; subsequently the acetate will be substituted with citrate anion for the 3 following months and then, the last 3 months, the standard acetate-solution will be restarted. The aim of the study is to assess if acetate-to-citrate switch in the dialysis solution influences dialysis efficiency and patient inflammatory state.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 45 patients with end stage renal disease will be treated with dialysis solution A (standard of care: acetate-buffered) for 3 months then with solution B (acetate-free, citrate buffered, otherwise identical to solution A) for 3 months and then with solution A for the final 3 months
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Dialysis Solutions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >18 years
- creatinine clearance <5ml/min
- treatment with bicarbonate HD (BIC-HD) or on-line hemodiafiltration (OL-HDF) 3 times per week for at least 6 months prior to study start
- treated at Dialysis unit of: Città della Salute e della Scienza University Hospital, Torino, Italy
Key exclusion criteria (3 listed)
- known neoplastic disease
- active chronic inflammatory disease
- active acute inflammatory disease
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 |
|---|---|---|
| Dialysis SolutionsSolution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion | Drug | Single arm |
Primary outcome
Change in serum CRP (C-reactive protein)
Time frame: Months 4th to 6th
Change in serum CRP during the 3 months of citrate-buffered dialysis
2 secondary outcomes
Change in dialysis efficiency
Time frame: Every 3 months (month 0, 6, 3 and completion - 9)
Change in serum CRP (C-reactive protein)
Time frame: Every 3 months (month 0, 6, 3 and completion - 9)
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 9 Jul 2018.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dialysis Solutions in people with Renal Insufficiency, Chronic and Inflammation, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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 3 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 9 Jul 2018. 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 Italy. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in serum CRP (C-reactive protein) (time frame: Months 4th to 6th). 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 9 Jul 2018.