Mycophenolate Mofetil, Carnitine and PDE5 Inhibitor, Three Potential Treatments for Resistant Proteinuria Slowing Diabetic Nephropathy Deterioration

NCT01566006 | Unknown DMC

• 1 other identifier: nazh8827ctil
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes mellitus (DM) is a growing disease and it is a public health concern, and projections of its future effect are alarming. About one third of those affected will develop diabetic nephropathy at 20 years after diagnosis. Of these patients, 20% will develop clinically end-stage renal disease ESRD, requiring renal replacement therapy (RRT). Patients with type 2 diabetes account for most patients with end stage renal disease (ESRD) and RRT. To the best of the investigators knowledge, the effects of MMF on diabetic nephropathy in patients with DM type II were not studied so far. Therefore, the purpose of this pilot study is to evaluate the effects of Mofetil Mycophenolate (MMF) on proteinuria and progression of kidney disease of diabetic origin, in patients at high risk for progressive renal failure in whom other treatment modalities are insufficient or had failed.

Conditions

Diabetic Nephropathy; Chronic Kidney Disease

Keywords

Mycophenolate mofetil (MMF); Diabetic Nephropathy; proteinuria; Diabetic Nephropathy in Chronic Kidney Disease patients stages 2-4

Outcome Measures

Primary Outcomes (1)

• proteinuria

  16 time points over 1 year.

  before beginging of the treatment - baseline, after 1,2,3,4 weeks, after 1,2,3,4,5,6,7,8,9,10,11,12 months of the beginning of the treatment

Study Arms (4)

control group

NO INTERVENTION

group receiving the conventional treatment for DN

Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE

cellcept group

EXPERIMENTAL

additional to the conventional treatment patients will receive cellcept

Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE

carnitine group

EXPERIMENTAL

aside to the conventional treatment patients will receive carnitine

Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE

PDE5 group

EXPERIMENTAL

aside to the conventional treatment patients will receive PDE5 inhibitor

Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE

Interventions

Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE DRUG

effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin

PDE5 group; carnitine group; cellcept group; control group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2 DM at age ≥18 y with at least 10 years duration of diabetes.
• Proteinuria due to diabetic nephropathy of ≥ 2 gram/d treated with ACEi or ARBs at maximal tolerated dose or both of them.
• CKD grade 1-3
• Diabetic retinopathy (discuss with Zaid)

You may not qualify if:

• Proteinuria of non diabetic origin
• Overlap Proteinuria with diabetic nephropathy
• Other intercurrent illness (fever due to infection ….) that can interfere with the urine protein secretion.
• Acute Kidney Injury.
• CKD stage 4-5.
• New renoprotective treatment in the last 6 months before enrollment.
• Changes in dosage of one of the renoprotective drugs in the last 6 months before enrollment.

Sponsors & Collaborators

• The Nazareth Hospital, Israel: lead
• Western Galilee Hospital-Nahariya: collaborator

Study Sites (1)

Nazareth hospital (EMMS)

Nazareth, Israel

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Renal Insufficiency, Chronic; Proteinuria

Interventions

Mycophenolic Acid; Phosphodiesterase 5 Inhibitors; Carnitine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Study Officials

• Zaher Armaly, MD

  Nazareth Hospital (E.M.M.S)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

najla hamati

CONTACT

04-6028888; nana@nazhosp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zaher armaly , M.D, Head of Nephrology Department, The Nazareth Hospital, Israel

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: March 29, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

IL (1)