Mild NephropathyPhase 1NCT00626249
Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function
A Phase 1 study testing Technosphere Inhalation Powder in people with Mild Nephropathy and Moderate Nephropathy, run by Mannkind Corporation at 3 sites in United States.
Trial summary
24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus
- What is being tested?
- Technosphere Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Oct 2008
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
- Type 1 or type 2 diabetic
- Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
- Normal pulmonary function and performance based on PFTs
Who cannot join
- No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
- No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
- No clinically significant major organ/systemic disease
- No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
- No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Davita Clinical Research
Minneapolis, Minnesota, 55404
Qualia Clinical Research
Omaha, Nebraska, 68154
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229
About this study
Official title: A Phase 1b, Single-Dose, Open Label, Parallel Design, Controlled Pharmacology Trial of Fumaryl Diketopiperazine Administered as Technosphere Inhalation Power in Subjects With Either Mild or Moderate Chronic Kidney Disease vs. Matched Subjects Without Chronic Kidney Disease
24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points
Read the detailed description
This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .
- Conditions
- Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus
- Being tested
- Technosphere Inhalation Powder
- Keywords
- Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics
- Medical subject headings
- Diabetes Mellitus, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technosphere Inhalation PowderDrug
Technosphere Inhalation Powder
| Study group | Role | What they receive |
|---|---|---|
| T Inhalation powder in diabetic subjs w/ normal renal func | Experimental | T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units Receives: Drug: Technosphere Inhalation Powder |
| T Inhalation powder diabetic subj w/mild or moderate nephrop | Experimental | T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units Receives: Drug: Technosphere Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in exposure to fumaryl diketopiperazine (FDKP)
Measured: 14 days
Secondary outcomes (1)
Additional safety parameters
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 posted29 Feb 2008 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild NephropathyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Boss, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626249
- Sponsor's protocol ID
- MKC-T-017
- Status last verified
- Dec 2013
- First submitted
- 21 Feb 2008
- Last updated
- 17 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Single-Dose, Open Label, Parallel Design, Controlled Pharmacology Trial of Fumaryl Diketopiperazine Administered as Technosphere Inhalation Power in Subjects With Either Mild or Moderate Chronic Kidney Disease vs. Matched Subjects Without Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00626249
- Acronym / sponsor ID
- MKC-T-017
- Conditions
- Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus
- Keywords
- Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Feb 2008 (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.
24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via MedTone® Inhaler and PK testing at 26 designated time points
Detailed description
This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T Inhalation powder in diabetic subjs w/ normal renal func | Experimental | Drug: Technosphere Inhalation PowderT inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units |
| T Inhalation powder diabetic subj w/mild or moderate nephrop | Experimental | Drug: Technosphere Inhalation PowderT Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
- Type 1 or type 2 diabetic
- Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
- Normal pulmonary function and performance based on PFTs
Key exclusion criteria (5 listed)
- No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
- No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
- No clinically significant major organ/systemic disease
- No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
- No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP
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 |
|---|---|---|
| Technosphere Inhalation PowderTechnosphere Inhalation Powder | Drug | T Inhalation powder diabetic subj w/mild or moderate nephrop, T Inhalation powder in diabetic subjs w/ normal renal func |
Primary outcome
Differences in exposure to fumaryl diketopiperazine (FDKP)
Time frame: 14 days
1 secondary outcome
Additional safety parameters
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 2013.
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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.
Anders Boss study director
Mannkind Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Technosphere Inhalation Powder in people with Mild Nephropathy and Moderate Nephropathy, run by Mannkind Corporation at 3 sites in United States.
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 5 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 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 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.
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?
Differences in exposure to fumaryl diketopiperazine (FDKP) (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 2013.