Chronic Kidney DiseasePhase 2DONATONCT01200784
Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
A Phase 2 study testing Nicotinamide in people with Chronic Kidney Disease and Hemodialysis, run by Medice Arzneimittel Pütter GmbH & Co KG at 36 sites in Germany.
Trial summary
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- What is being tested?
- Nicotinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 36 sitesGermany
- Study dates
- Aug 2010to Jul 2011
- Phase
- Phase 2
- 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 since 3 months or longer
- hemodialysis frequency 3 times weekly
- stable phosphate binder dose since one month at screening
- serum phosphate level < 2,42 mmol/l at screening
- serum phosphate level > 1,52 mmol/l after wash out phase
- stable treatment with vitamin D analogues since one month at screening
Who cannot join
- congestive heart failure
- acute bleeding complications
- acute myocardial infarction
- peptic ulcers
- serious liver damage
- poorly controlled diabetes
Show all 12Show fewer
- severe visual impairment
- uncontrolled high blood pressure
- thrombocyte count < 120/nl
- difficulties in swallowing or dysphagia
- diminished intestinal motility, megacolon, pseudo- or mechanical obstruction
- gastroparesis
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Germany36 sites
Study site
Alsfeld, 36304
Study site
Arnstadt, 99310
Study site
Augsburg, 86157
Study site
Berlin, 12045
Study site
Berlin, 12203
Study site
Berlin, 12435
Study site
Berlin, 13051
Study site
Bielefeld, 33602
Study site
Coburg, 96450
Study site
Darmstadt, 64295
Study site
Dortmund, 44135
Study site
Dülmen, 48249
Study site
Düsseldorf, 40210
Study site
Elsenfeld, 63820
Study site
Erfurt, 99089
Study site
Essen, 45127
Study site
Friedrichsroda, 99894
Study site
Hamburg, 22297
Study site
Hamelin, 31787
Study site
Hellersdorf, 12627
Study site
Herne, 44623
Study site
Herzberg, 04916
Study site
Iserlohn, 58638
Study site
Jena-Drakendorf, 07751
Study site
Kamen, 59174
Study site
Kreuzberg, 10245
Study site
Leverkusen, 51373
Study site
Mannheim, 68309
Study site
Minden, 32429
Study site
Nordhausen, 99734
Study site
Osnabrück, 49074
Study site
Pfarrkirchen, 84347
Study site
Regensburg, 93053
Study site
Schwabach, 91126
Study site
Tangermünde, 39590
Study site
Wuppertal, 42283
About this study
Official title: Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- Being tested
- Nicotinamide
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDrug
dosage
| Study group | Role | What they receive |
|---|---|---|
| 250 mg/d modified release Nicotinamide | Experimental | Not described Receives: Drug: Nicotinamide |
| 500 mg/d modified release Nicotinamide | Experimental | Not described Receives: Drug: Nicotinamide |
| 750 mg/d modified release Nicotinamide | Experimental | Not described Receives: Drug: Nicotinamide |
| 1000 mg/d modified release Nicotinamide | Experimental | Not described Receives: Drug: Nicotinamide |
| 1000 mg/d immidiate release Nicotinamide | Active comparator | Not described Receives: Drug: Nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum phosphate
Measured: 4 weeks of active treatment
Secondary outcomes (4)
serum phosphate
Measured: 8 weeks of active treatment
serum calcium
Measured: 4 and 8 weeks of acitve treatment
serum PTH
Measured: 4 and 8 weeks of active treatment
adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Zidek, Prof. Dr., Study director, Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200784
- Sponsor's protocol ID
- 6520-9961-03
- Other IDs
- 2009-015821-34, 2009
- Acronym
- DONATO
- Status last verified
- Jan 2012
- First submitted
- 10 Sep 2010
- Last updated
- 18 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT01200784
- Acronym / sponsor ID
- DONATO / 6520-9961-03
- Conditions
- Chronic Kidney Disease, Hemodialysis, Hyperphosphatemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Sep 2010 (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.
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 250 mg/d modified release Nicotinamide | Experimental | Drug: Nicotinamide |
| 500 mg/d modified release Nicotinamide | Experimental | Drug: Nicotinamide |
| 750 mg/d modified release Nicotinamide | Experimental | Drug: Nicotinamide |
| 1000 mg/d modified release Nicotinamide | Experimental | Drug: Nicotinamide |
| 1000 mg/d immidiate release Nicotinamide | Active comparator | Drug: Nicotinamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hemodialysis since 3 months or longer
- hemodialysis frequency 3 times weekly
- stable phosphate binder dose since one month at screening
- serum phosphate level < 2,42 mmol/l at screening
- serum phosphate level > 1,52 mmol/l after wash out phase
Key exclusion criteria (12 listed)
- congestive heart failure
- acute bleeding complications
- acute myocardial infarction
- peptic ulcers
- serious liver damage
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 |
|---|---|---|
| Nicotinamidedosage | Drug | 1000 mg/d immidiate release Nicotinamide, 1000 mg/d modified release Nicotinamide, 250 mg/d modified release Nicotinamide, 500 mg/d modified release Nicotinamide, 750 mg/d modified release Nicotinamide |
Primary outcome
serum phosphate
Time frame: 4 weeks of active treatment
4 secondary outcomes
serum phosphate
Time frame: 8 weeks of active treatment
serum calcium
Time frame: 4 and 8 weeks of acitve treatment
serum PTH
Time frame: 4 and 8 weeks of active treatment
adverse events
Time frame: 12 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 18 Jan 2012.
Related trials for Chronic Kidney 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
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
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.
Walter Zidek, Prof. Dr. study director
Charité Berlin, Campus Benjamin Franklin, Innere Medizinische Klinik IV WE 28
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide in people with Chronic Kidney Disease and Hemodialysis, run by Medice Arzneimittel Pütter GmbH & Co KG at 36 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 6 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 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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.
What does this 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.
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?
serum phosphate (time frame: 4 weeks of active treatment). 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 18 Jan 2012.