A Phase I Clinical Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36

Renal Impairment Clinical Trial

Official title:

A Phase I, Open Label, Parallel Group, Multi-center Single Dose Trial to Evaluate the Effect of Renal Impairment on Pharmacokinetics of NOX-E36

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372124
• Other study ID #: SNOXE36C201
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2011
• Last updated: October 18, 2012
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: NOXXON Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyMoldova: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This is a multi center, open label, parallel group, single administration, phase I trial, in subjects with mild, moderate or severe renal impairment and a control group with normal renal function.

Description:

Current diabetes therapy does not stop progression of the disease and the development of diabetes mellitus (DM)-associated complications. A major concern in DM-patients is renal impairment due to nephropathy leading to a reduced glomerular filtration rate (GFR). It has been established that chronic (sub)clinical inflammation is crucial for the onset and progression of DM.

CCL2, also known as Monocyte chemoattractant protein 1 (MCP 1) is a chemokine from the cysteine-cysteine family, secreted by leukocytes or tissue cells. CCL2 promotes monocyte emigration from the bone marrow, activates monocytes and macrophages and directs their migration to sites of inflammation. Recent animal studies and clinical trials indicate a critical involvement of CCL2 in DM and diabetic nephropathy, suggesting that CCL2 may be a potential target for therapeutic intervention in DM. Finally, protein overload and oxidative challenge of the diseased kidney was suggested to stimulate CCL2 expression in renal tubuli, thereby accelerating the progression of diabetic nephropathy.

As NOX E36 is designed to specifically target human MCP-1/CCL2. This study is performed to evaluate the role of renal impairment for adequate dosing recommendations in the planned target population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects (age 18-75 years, both inclusive)

2. Male subjects who agree to sexual abstinence and/or use a highly effective method of birth control. Female partners of male subjects must be of non-child bearing potential or must practice an adequate non-hormonal contraceptive method to prevent pregnancies.

3. Subjects will be categorized as follows based on creatinine clearance(mL/min/1.73m2):

Normal renal function: CrCl > 80; mild renal impairment: 50 = CrCl = 80; moderate renal impairment: 30 = CrCl = 50; severe renal impairment: CrCl < 30

4. Body Mass Index (BMI) between 22 and 40 kg/m², both inclusive.

Exclusion Criteria:

1. Women of childbearing potential

2. Patients who have received kidney transplantation.

3. Patients receiving hemodialysis to control their disease.

4. Any clinically significant abnormality other than related to the renal impairment following the investigator's review of the physical examination, ECG and clinical laboratory tests at screening.

5. Not able to communicate meaningfully with the investigator and staff.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• NOX-E36
All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity

Locations

Country	Name	City	State
Hungary	DRC	Balatonfüred
Moldova, Republic of	Innophar Mo S.R.L.	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
NOXXON Pharma AG

Countries where clinical trial is conducted

Hungary,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics			No