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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

NCT ID: NCT00626249

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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

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Mild Nephropathy Moderate Nephropathy Diabetes Mellitus

Keywords

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Nephropathy Kidney Disease Diabetic Renal Diabetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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T Inhalation powder in diabetic subjs w/ normal renal func

T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units

Group Type EXPERIMENTAL

Technosphere Inhalation Powder

Intervention Type DRUG

Technosphere Inhalation Powder

T Inhalation powder diabetic subj w/mild or moderate nephrop

T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units

Group Type EXPERIMENTAL

Technosphere Inhalation Powder

Intervention Type DRUG

Technosphere Inhalation Powder

Interventions

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Technosphere Inhalation Powder

Technosphere Inhalation Powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mannkind Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Boss

Role: STUDY_DIRECTOR

Mannkind Corporation

Locations

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Davita Clinical Research

Minneapolis, Minnesota, United States

Site Status

Qualia Clinical Research

Omaha, Nebraska, United States

Site Status

Diabetes & Glandular Disease Research Assoc PA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MKC-T-017

Identifier Type: -

Identifier Source: org_study_id