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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626249
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):
Mannkind Corporation

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

Condition or disease Intervention/treatment Phase
Mild Nephropathy Moderate Nephropathy Diabetes Mellitus Drug: Technosphere Inhalation Powder Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: T Inhalation powder in diabetic subjs w/ normal renal func
T inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
Drug: Technosphere Inhalation Powder
Technosphere Inhalation Powder

Experimental: 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
Drug: Technosphere Inhalation Powder
Technosphere Inhalation Powder

Primary Outcome Measures :
  1. Differences in exposure to fumaryl diketopiperazine (FDKP) [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Additional safety parameters [ Time Frame: 14 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626249

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
Study Director: Anders Boss Mannkind Corporation

Responsible Party: Mannkind Corporation Identifier: NCT00626249     History of Changes
Other Study ID Numbers: MKC-T-017
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Mannkind Corporation:
Kidney Disease

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