Nephroprotective Effects of Carnitine and (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by The Nazareth Hospital, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Western Galilee Hospital-Nahariya
Information provided by (Responsible Party):
The Nazareth Hospital, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier:
NCT01564303
First received: March 22, 2012
Last updated: March 24, 2012
Last verified: March 2012
  Purpose

CIAKI is a common iatrogenic. Up to date the suggested treatments for CIAKI are partially effective and have not been approved by the Food and Drug Administration yet. The lack of effective nephroprotective drug for CIAKI, emphasizes the need not only for additional new drugs but also for new strategies that might also clarify CIAKI pathophysiology. To the best of our knowledge, the potentially beneficial effect of carnitine and PDE5 inhibitors on CIAKI prevention has not been examined, so far.


Condition Intervention
Contrast Media Induced Nephropathy
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Potentially Nephroprotective Effects of Carnitine and Phosphodiesterase Type 5 (PDE5) Inhibitor Agent Against Contrast Media-induced Nephropathy (CMN): A Double Blind Randomized Study

Resource links provided by NLM:


Further study details as provided by The Nazareth Hospital, Israel:

Primary Outcome Measures:
  • Kidney functioning biomarker [ Time Frame: NGAL and creatinine will be assessed before CT and 2, 6, 12,24,48,120 hours after CT ] [ Designated as safety issue: Yes ]
    7 time points over 6 days


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 2. Acetylcysteine group (NAC+S) , aside with the saline, will
2. Acetylcysteine group (NAC+S) , aside with the saline, patients will be given orally Acetylcysteine at a dose of 600 mg twice daily, on the day before and on the day of administration of the contrast agent.
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
Experimental: CAR+S , aside with the saline, carnitne will be adminstrated
Carnitine group (Car+S), aside with the saline, patients will be administrated with 20 mg/kg carnitine over 10 minutes 2 hours prior to the administration of the contrast agent and 8 hours after CT.
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
Experimental: Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with
4. Phosphodiesterase type 5 inhibitor group (PDE5+S), aside with the saline patients will be given orally 20 mg tablets of PDE5 Tadalafil once daily 2 hours prior to the administration of the contrast agent and in the subsequent day.
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters
No Intervention: Control group (S) will be treated without any extra agents
Control group ( S ) , which will be treated without any extra agents, just Saline (0.9 %) will be given I.V. at a rate of 1 ml per kilogram of body weight per hour for 12 hours before and 12 hours after administration of the contrast agent.
Drug: Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine
to evaluate the effect of the above agents on Kidney functioning parameters

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of 18 years old or older
  2. CKD stage 3 according to GFR-MDRD equation.
  3. Two consecutive stable plasma Creatinine levels during the last 2months.
  4. Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent.

Exclusion Criteria:

  1. Acute/ chronic renal failure. Acute renal failure is defined as a change in serum creatinine concentration of at least 0.5 mg/dL, or 25% from creatinine measured before the study to that of the day of the procedure.
  2. Intercurrent illness: e.g. fever… etc.
  3. Recent exposure to radiographic contrast media in the last month before enrollment.
  4. Allergy to contrast agents, PDE inhibitors or NAC.
  5. Hypotension
  6. Pregnancy and lactation
  7. Multiple Myeloma
  8. Intravenous diuretics therapy
  9. Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason.
  10. Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C).
  11. Concomitant use of Nitrates, CYP3A inhibitors (e.g Ketonazole, Itraconazole) or Inducers (e.g Rifampin)
  12. Therapy with potential nephrotoxicity such as NSAID OR COX2 Inhibitors, Aminoglycosides, and Amphotericin B, Cisplatin, etc in the last two weeks before enrollment or within 5 days following the procedure.
  13. Therapy with Metformin in the last 48 hours before the procedure.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564303

Contacts
Contact: najlah hamati 046028888 nana@nazhosp.com

Locations
Israel
Nazreth Hospital Not yet recruiting
Nazareth, Israel, 16100
Contact: amir abed, msc    0507209343    amir_abed@nazhosp.com   
Sponsors and Collaborators
The Nazareth Hospital
Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: The Nazareth Hospital, Zaher Armaly M.D. , Head of Nephrology Department, The Nazareth Hospital, Israel
ClinicalTrials.gov Identifier: NCT01564303     History of Changes
Other Study ID Numbers: nazh7343ctil
Study First Received: March 22, 2012
Last Updated: March 24, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by The Nazareth Hospital, Israel:
Carnitine
Phosphodiesterase type 5 (PDE5) inhibitor
Contrast Media-induced Nephropathy (CMN)

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Carnitine
Contrast Media
Phosphodiesterase 5 Inhibitors
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Diagnostic Uses of Chemicals
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014