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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00626249
First received: February 21, 2008
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Mild Nephropathy
Moderate Nephropathy
Diabetes Mellitus
 Drug: Technosphere Inhalation Powder
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • Differences in exposure to fumaryl diketopiperazine (FDKP) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Additional safety parameters [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Technosphere Inhalation Powder
    Technosphere Inhalation Powder
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 .

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626249

Locations
United States, Minnesota
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Qualia Clinical Research
Omaha, Nebraska, United States, 68154
United States, Texas
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Director: Anders Boss Mannkind Corporation
  More Information

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00626249     History of Changes
Other Study ID Numbers: MKC-T-017
Study First Received: February 21, 2008
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:
Nephropathy
Kidney Disease
Diabetic
Renal
Diabetics

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013