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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

Primary Purpose

Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Technosphere Inhalation Powder
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Nephropathy focused on measuring Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Davita Clinical Research
  • Qualia Clinical Research
  • Diabetes & Glandular Disease Research Assoc PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

T Inhalation powder in diabetic subjs w/ normal renal func

T Inhalation powder diabetic subj w/mild or moderate nephrop

Arm Description

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

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

Outcomes

Primary Outcome Measures

Differences in exposure to fumaryl diketopiperazine (FDKP)

Secondary Outcome Measures

Additional safety parameters

Full Information

First Posted
February 21, 2008
Last Updated
December 13, 2013
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00626249
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

5. Study Description

Brief 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
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus
Keywords
Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T Inhalation powder in diabetic subjs w/ normal renal func
Arm Type
Experimental
Arm Description
T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
Arm Title
T Inhalation powder diabetic subj w/mild or moderate nephrop
Arm Type
Experimental
Arm Description
T Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units
Intervention Type
Drug
Intervention Name(s)
Technosphere Inhalation Powder
Intervention Description
Technosphere Inhalation Powder
Primary Outcome Measure Information:
Title
Differences in exposure to fumaryl diketopiperazine (FDKP)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Additional safety parameters
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Boss
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Davita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Qualia Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
Facility Name
Diabetes & Glandular Disease Research Assoc PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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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

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