Renal ImpairmentPhase 1/2NCT00818571
Pharmacokinetics of Vildagliptin in Mild, Moderate and Severe Renal Impaired Patients
A Phase 1/2 study testing Vildagliptin in people with Renal Impairment and Diabetes, run by Novartis Pharmaceuticals at 1 site in Russia.
Trial summary
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment, Diabetes
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2008to May 2009
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min
Who cannot join
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
- Conditions
- Renal Impairment, Diabetes
- Being tested
- Vildagliptin
- Keywords
- Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Mild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily
VildagliptinDrug
Mild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily
VildagliptinDrug
Matching healthy volunteers receiving 25 mg vildagliptin once daily.
VildagliptinDrug
Matching healthy volunteers receiving 50 mg vildagliptin once daily
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin 25 mg qd in Renal Impaired (RI) patients | Experimental | Not described Receives: Drug: Vildagliptin |
| Vildagliptin 50 mg qd in RI Patients | Experimental | Not described Receives: Drug: Vildagliptin |
| Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) | Experimental | Not described Receives: Drug: Vildagliptin |
| Vildagliptin 50 mg qd in matched HV | Experimental | Not described Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: pharmacokinetics of vildagliptin and its metabolites
Measured: 14 days
Secondary outcomes (1)
Measure: safety assessments will include vital signs, electrocardiograms and adverse events
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818571
- Sponsor's protocol ID
- CLAF237B2202
- Other IDs
- 2008-004565-25, 2008
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2009
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Parallel Group Study to Determine the PK of 25 and 50 mg OD Single and Multiple Dose Over 14 Days, of Vildagliptin and Its Metabolites in Renal Impaired Patients Compared to Matching Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00818571
- Acronym / sponsor ID
- CLAF237B2202
- Conditions
- Renal Impairment, Diabetes
- Keywords
- Renal impairment, Diabetes, vildagliptin, Galvus, Eucreas
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- First posted
- 7 Jan 2009 (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.
This study assess the pharmacokinetics of vildagliptin in mild, moderate and severe renal impaired patients
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin 25 mg qd in Renal Impaired (RI) patients | Experimental | Drug: Vildagliptin |
| Vildagliptin 50 mg qd in RI Patients | Experimental | Drug: Vildagliptin |
| Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) | Experimental | Drug: Vildagliptin |
| Vildagliptin 50 mg qd in matched HV | Experimental | Drug: Vildagliptin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mild (CrCl from 50 to ≤80 ml/min), moderate (CrCl from 30 to <50 ml/min) and severe (CrCl of <30 ml/min) renal function, preferably type 2 diabetic and matching healthy volunteers CrCl of >80 ml/min
Key exclusion criteria (2 listed)
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications, treatment of a DPP-4 inhibitor 30 days prior to baseline, renal transplant history
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| VildagliptinMild, moderate and severe renal impaired patients receiving 25 mg vildagliptin once daily | Drug | Vildagliptin 25 mg qd in Renal Impaired (RI) patients |
| VildagliptinMild, moderate and severe renal impaired patients receiving 50 mg vildagliptin once daily | Drug | Vildagliptin 50 mg qd in RI Patients |
| VildagliptinMatching healthy volunteers receiving 25 mg vildagliptin once daily. | Drug | Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) |
| VildagliptinMatching healthy volunteers receiving 50 mg vildagliptin once daily | Drug | Vildagliptin 50 mg qd in matched HV |
Primary outcome
Measure: pharmacokinetics of vildagliptin and its metabolites
Time frame: 14 days
1 secondary outcome
Measure: safety assessments will include vital signs, electrocardiograms and adverse events
Time frame: 14 days
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 17 Dec 2020.
- Results for CLAF237B2202 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vildagliptin in people with Renal Impairment and Diabetes, run by Novartis Pharmaceuticals at 1 site in Russia.
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 1 inclusion and 2 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 17 Dec 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 Russia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measure: pharmacokinetics of vildagliptin and its metabolites (time frame: 14 days). 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 17 Dec 2020.