MalnutritionPhase 4IDPNHDNCT00501956
Intradialytic Parenteral Nutrition in Hemodialysis Patients
A Phase 4 study testing Intradialytic Parenteral Nutrition (IDPN) in people with Malnutrition and Complication of Hemodialysis, run by Fresenius Kabi at 1 site in Germany.
Trial summary
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Complication of Hemodialysis
- What is being tested?
- Intradialytic Parenteral Nutrition (IDPN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hemodialysis therapy more than 6 months
- three times per week hemodialysis
- albumin < 35 g/l
- prealbumin < 250 mg/l
- phase angle < 4,5°
- SGA score grade B or C
- informed consent
Who cannot join
- inadequate dialysis (Kt/V < 1,2)
- chemotherapy or radiotherapy
- cardiac pacemaker
- acute bacterial infection
- acute immunological disease
- cancer disease
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- severe hepatic insufficiency
- interferon therapy
- HIV disease
- severe diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
In cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients.
Effectiveness of IDPN has to be verified.
Read the detailed description
25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.
The conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.
IDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.
Some publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.
In this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.
The parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score).
- Conditions
- Malnutrition, Complication of Hemodialysis
- Being tested
- Intradialytic Parenteral Nutrition (IDPN)
- Keywords
- chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition
- Medical subject headings
- Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic Parenteral Nutrition (IDPN)Drug
Also called Individually compounded parenteral nutrition
compounded IDPN, 3 x/week, 16 weeks intervention
| Study group | Role | What they receive |
|---|---|---|
| Intradialytic parenteral nutrition | Experimental | Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation. Receives: Drug: Intradialytic Parenteral Nutrition (IDPN) |
| Control Group | No intervention | Observation over 28 weeks (16 + 12 weeks). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prealbumin levels
Measured: 8 weeks
Secondary outcomes (1)
Serum albumin, transferrin, nutritional status
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startJul 2004
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Clinical Research
- Responsible party
- Sponsor
- Investigators
- Helmut Mann, Prof. Dr., Principal investigator, Interneph e.V, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501956
- Sponsor's protocol ID
- IDPN 24332
- Acronym
- IDPNHD
- Status last verified
- Mar 2016
- First submitted
- 16 Jul 2007
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.
PubMed 12189236Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.
PubMed 26708726
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00501956
- Acronym / sponsor ID
- IDPNHD / IDPN 24332
- Conditions
- Malnutrition, Complication of Hemodialysis
- Keywords
- chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Clinical Research
- Study start
- Jul 2004
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Jul 2007 (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.
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.
In cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients.
Effectiveness of IDPN has to be verified.
Detailed description
25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.
The conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.
IDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.
Some publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.
In this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.
The parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradialytic parenteral nutrition | Experimental | Drug: Intradialytic Parenteral Nutrition (IDPN)Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation. |
| Control Group | No intervention | –Observation over 28 weeks (16 + 12 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- hemodialysis therapy more than 6 months
- three times per week hemodialysis
- albumin < 35 g/l
- prealbumin < 250 mg/l
- phase angle < 4,5°
Key exclusion criteria (10 listed)
- inadequate dialysis (Kt/V < 1,2)
- chemotherapy or radiotherapy
- cardiac pacemaker
- acute bacterial infection
- acute immunological 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 |
|---|---|---|
| Intradialytic Parenteral Nutrition (IDPN)Also: Individually compounded parenteral nutritioncompounded IDPN, 3 x/week, 16 weeks intervention | Drug | Intradialytic parenteral nutrition |
Primary outcome
Change in prealbumin levels
Time frame: 8 weeks
1 secondary outcome
Serum albumin, transferrin, nutritional status
Time frame: 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 3 Mar 2016.
- Background: PubMed 12189236Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.
- Derived from this study: PubMed 26708726Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.
- 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.
Helmut Mann, Prof. Dr. principal investigator
Interneph e.V, Aachen
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 Intradialytic Parenteral Nutrition (IDPN) in people with Malnutrition and Complication of Hemodialysis, run by Fresenius Kabi at 1 site 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 7 inclusion and 10 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 3 Mar 2016. 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 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.
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?
Change in prealbumin levels (time frame: 8 weeks). 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 NCT00501956, which also lists 2 linked publications.
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 3 Mar 2016.