Renal InsufficiencyPhase 4DIDoNCT01944852
Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental PD.
A Phase 4 study testing Icodextrin in people with Renal Insufficiency, run by Pr Eric Goffin at 1 site in Belgium.
Trial summary
The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum : One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Icodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to 28 Feb 2020
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Run-in period
- Incident CAPD patients who require incremental PD and in whom a 1.5L dialysate can be safely instilled,
- Creatinine clearance < 20 ml / min (calculated with the modification of the Diet in renal Disease [MDRD] formula),
- Age ≥ 60 years,
- Patients willing and able to give written informed consent and comply with the requirements of the study protocol.
- Treatment period
- Patients having successfully completed the run-in period (achieving euvolemia)
Who cannot join
- Run-in period
- Contraindication for CAPD according to local practice,
- Life expectancy < 6 months,
- Known allergy to icodextrin (cloudy dialysate or skin rash),
- Need for amino-acid prescription,
- Treatment with any investigational product within 30 days prior to signature of the informed consent form (ICF)
Show all 12Show fewer
- History of drug or alcohol abuse within 3 months prior to the signature of the ICF.
- Treatment period
- Severe symptomatic arterial hypotension at the end the run-in period in the Investigator's opinion,
- Excessive ultrafiltration (UF) during the run-in period,
- Allergy to icodextrin discovered during the run-in period,
- Impossibility to achieve adequate PD regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psychosocial reasons)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study
The DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum :
- One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose
- One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.
Read the detailed description
The DiDo study evaluates efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy.
The objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (CAPD) patients using incremental peritoneal dialysis (PD) (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.
This is a phase IV open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un Europe.
It is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). The duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited.
There are 2 periods: a run-in period of 2 months and a treatment period of 18 months.
- Conditions
- Renal Insufficiency
- Being tested
- Icodextrin
- Keywords
- icodextrin, double dose, elderly incident CAPD patients, DIDo study
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcodextrinDrug
Also called Extraneal
| Study group | Role | What they receive |
|---|---|---|
| 2 icodextrin bags/day | Experimental | 2 icodextrin bags + 1 glucose per day Receives: Drug: Icodextrin |
| 1 icodextrin bag/day | Active comparator | 1 icodextrin bag + 2 glucose bags per day Receives: Drug: Icodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients stopping 3 bags / day
The primary endpoint will be the proportion of patients stopping 3 bags / day for the following reasons:
- Use of > 15 % hypertonic glucose dialysate 3.86 % or > 30 % hypertonic glucose dialysate 2.27 % over a 4-week period19-20,
- Transfer of the patient to another dialysis method (HD, APD, CAPD with > 3 bags / day) for any reason,
- Death of the patient.
Measured: During the treatment phase of 18 months
Secondary outcomes (14)
effect on clinical and biological determinants
- Metabolic control: HbA1c and lipid concentration (total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol)
Measured: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
- Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit
Measured: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
- Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2)
Measured: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
- Inflammatory profile: CRP concentrations
Measured: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
- Left ventricular mass calculated following echocardiography
Measured: Month 9 and month 18.
effect on clinical and biological determinants
- Quality of life according to KDQoL
Measured: Month 6, 12 and 18.
effect on clinical and biological determinants
- Residual renal function evaluated by calculated GFR
Measured: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
- Peritoneal membrane permeability assessed by the PET
Measured: On month 6, 12 and 18.
effect on clinical and biological determinants
- Number of hospitalisations and length (in days) of hospitalisation
Measured: During the treatment phase of 18 months.
Safety endpoints
- Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs)
Measured: Durign the treatment phase of 18 months.
6.1.3 Safety endpoints
- Serum sodium concentration and icodextrin metabolites concentration
Measured: On month 3, 6, 12 and 18.
safety endpoints
- Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation
Measured: During the treatment phase of 18 months.
Safety endpoints
- Incidence of skin rashes
Measured: During the treatment phase of 18 months.
Safety endpoints
- Incidence of sterile peritonitis
Measured: During the treatment phase of 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startMar 2013
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
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 Renal InsufficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Eric Goffin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Eric Goffin, Université Catholique de Louvain
- Investigators
- Eric Goffin, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944852
- Sponsor's protocol ID
- UCL_2011_DIDo
- Acronym
- DIDo
- Status last verified
- Nov 2020
- First submitted
- 2 Sep 2013
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Morelle J, Lambie M, Oberg CM, Davies S. The Peritoneal Membrane and Its Role in Peritoneal Dialysis. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):244-253. doi: 10.2215/CJN.0000000000000282. Epub 2023 Aug 24.
PubMed 37616463
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Double Icodextrin Dose in Elderly Incident CAPD Patients on Incremental Peritoneal Dialysis Therapy: the DIDo Study
- ClinicalTrials.gov ID
- NCT01944852
- Acronym / sponsor ID
- DIDo / UCL_2011_DIDo
- Conditions
- Renal Insufficiency
- Keywords
- icodextrin, double dose, elderly incident CAPD patients, DIDo study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Pr Eric GoffinUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 18 Sep 2013 (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 DIDo study is an open-label, randomised, multicentre study with 2 parallel groups in incident CAPD patients aged of 65 at minimum :
- One group in which patients will receive 2 bags of icodextrin/day and 1 bag of glucose
- One group in which patients will receive 1 bag of icodextrin/day and 2 bags of glucose.
Detailed description
The DiDo study evaluates efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy.
The objective is to demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident continuous ambulatory peritoneal dialysis (CAPD) patients using incremental peritoneal dialysis (PD) (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.
This is a phase IV open-label, randomised, multicentre study with 2 parallel groups, which will take place in up to 30 hospital out-patient clinics un Europe.
It is planned to include 160 patients on the run-in period in order to obtain 100 randomised patients and 90 patients evaluable at the primary endpoint (45 in each group). The duration of patient recruitment is estimated at 1 year but this may be extended until all 160 patients are recruited.
There are 2 periods: a run-in period of 2 months and a treatment period of 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 icodextrin bags/day | Experimental | Drug: Icodextrin2 icodextrin bags + 1 glucose per day |
| 1 icodextrin bag/day | Active comparator | Drug: Icodextrin1 icodextrin bag + 2 glucose bags per day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Run-in period
- Incident CAPD patients who require incremental PD and in whom a 1.5L dialysate can be safely instilled,
- Creatinine clearance < 20 ml / min (calculated with the modification of the Diet in renal Disease [MDRD] formula),
- Age ≥ 60 years,
- Patients willing and able to give written informed consent and comply with the requirements of the study protocol.
Key exclusion criteria (12 listed)
- Run-in period
- Contraindication for CAPD according to local practice,
- Life expectancy < 6 months,
- Known allergy to icodextrin (cloudy dialysate or skin rash),
- Need for amino-acid prescription,
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 |
|---|---|---|
| IcodextrinAlso: Extraneal | Drug | 1 icodextrin bag/day, 2 icodextrin bags/day |
Primary outcome
Proportion of patients stopping 3 bags / day
Time frame: During the treatment phase of 18 months
The primary endpoint will be the proportion of patients stopping 3 bags / day for the following reasons: * Use of > 15 % hypertonic glucose dialysate 3.86 % or > 30 % hypertonic glucose dialysate 2.27 % over a 4-week period19-20, * Transfer of the patient to another dialysis method (HD, APD, CAPD with > 3 bags / day) for any reason, * Death of the patient.
14 secondary outcomes
effect on clinical and biological determinants
Time frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time frame: Month 9 and month 18.
effect on clinical and biological determinants
Time frame: Month 6, 12 and 18.
effect on clinical and biological determinants
Time frame: During 18 months, evaluated on month 3, 6, 9, 12 and 18.
effect on clinical and biological determinants
Time frame: On month 6, 12 and 18.
effect on clinical and biological determinants
Time frame: During the treatment phase of 18 months.
Safety endpoints
Time frame: Durign the treatment phase of 18 months.
6.1.3 Safety endpoints
Time frame: On month 3, 6, 12 and 18.
safety endpoints
Time frame: During the treatment phase of 18 months.
Safety endpoints
Time frame: During the treatment phase of 18 months.
Safety endpoints
Time frame: During the treatment phase of 18 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 10 Nov 2020.
- Derived from this study: PubMed 37616463Morelle J, Lambie M, Oberg CM, Davies S. The Peritoneal Membrane and Its Role in Peritoneal Dialysis. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):244-253. doi: 10.2215/CJN.0000000000000282. Epub 2023 Aug 24.
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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.
Eric Goffin principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icodextrin in people with Renal Insufficiency, run by Pr Eric Goffin at 1 site in Belgium.
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 7 inclusion and 12 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 10 Nov 2020. 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 Belgium. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients stopping 3 bags / day (time frame: During the treatment phase of 18 months). 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 NCT01944852, 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 10 Nov 2020.