Mycophenolate Mofetil, Carnitine and PDE5 Inhibitor, Three Potential Treatments for Resistant Proteinuria Slowing Diabetic Nephropathy Deterioration (Myridian)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01566006 |
Recruitment Status
: Unknown
Verified March 2012 by The Nazareth Hospital, The Nazareth Hospital, Israel.
Recruitment status was: Not yet recruiting
First Posted
: March 29, 2012
Last Update Posted
: March 29, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Nephropathy Chronic Kidney Disease | Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE | Not Applicable |
The pathophysiology of the diabetic nephropathy was initially considered to be merely secondary to a non-immune mechanism, specifically due to metabolic (hyperglycemia) and hemodynamic (glomerular capillary hypertension - mechanical stretching) factors. However, our understanding of the pathophysiological processes that lead to diabetic nephropathy and its progression is now clearer and involved not only a non immune mechanism, but also immune-mediated and inflammatory mechanism. Activation of the immune system, with the participation of a chronic inflammatory state, plays a central role in the pathogenesis of diabetic nephropathy. Evidence for the involvement of the immune system in the pathogenesis of diabetic nephropathy was derived from the elevated levels of proinflammatory cytokines such as IL-1, IL-6, IL-18, and TNF-α. These factors are important predictors of the development of diabetic nephropathy, and recently it was shown that these inflammatory cytokines play a determinant role in the development and progression of the microvascular diabetic nephropathy. The first published study that showed the implication of the inflammatory cytokines in the pathogenesis of the diabetic nephropathy was in 1991. Mycophenolate Mofetil (MMF) is an immunosuppressant drug, used to prevent rejection, especially acute rejection in various organ transplantations, mainly kidney transplantation since 1995. In the last decade there are increasing reports describing the beneficial use of MMF in immune- mediated and auto-immune disorders such as Systemic Lupus Erythematosus, IGA nephropathy and other glomerulopathies.
Unfortunately, the potentially beneficial effects of MMF on diabetic nephropathy were not examined in clinical DM and is limited to diabetic rats. In a recent study, Utimura et al. have demonstrated that MMF largely prevented the development of albuminuria and glomerular injury in experimental diabetic nephropathy. The beneficial effect of MMF was not related to its action on glomerular hemodynamic or improvement of metabolic control, but probably related directly to its immunosuppressive and anti-inflammatory properties.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Mycophenolate Mofetil (MMF) ,Carnitine and Phosphodiesterase Type 5 Inhibitor, Three Potential Treatments for Resistant Proteinuria and for Slowing the Deterioration of Diabetic Nephropathy in Patients With Type II Diabetes Mellitus |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | June 2013 |
Estimated Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
No Intervention: control group
group receiving the conventional treatment for DN
|
Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE
effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin
|
Experimental: cellcept group
additional to the conventional treatment patients will receive cellcept
|
Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE
effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin
|
Experimental: carnitine group
aside to the conventional treatment patients will receive carnitine
|
Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE
effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin
|
Experimental: PDE5 group
aside to the conventional treatment patients will receive PDE5 inhibitor
|
Drug: Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE
effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin
|
- proteinuria [ Time Frame: 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 ]16 time points over 1 year.

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: | 30 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.

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 ClinicalTrials.gov identifier (NCT number): NCT01566006
Contact: najla hamati | 04-6028888 | nana@nazhosp.com |
Israel | |
Nazareth hospital (EMMS) | Not yet recruiting |
Nazareth, Israel | |
Contact: Zaher Armaly, MD zaherarmaly@nazhosp.com |
Principal Investigator: | Zaher Armaly, MD | Nazareth Hospital (E.M.M.S) |
Responsible Party: | The Nazareth Hospital, Zaher armaly , M.D, Head of Nephrology Department, The Nazareth Hospital, Israel, The Nazareth Hospital, Israel |
ClinicalTrials.gov Identifier: | NCT01566006 History of Changes |
Other Study ID Numbers: |
nazh8827ctil |
First Posted: | March 29, 2012 Key Record Dates |
Last Update Posted: | March 29, 2012 |
Last Verified: | March 2012 |
Keywords provided by The Nazareth Hospital, The Nazareth Hospital, Israel:
Mycophenolate mofetil (MMF) Diabetic Nephropathy proteinuria Diabetic Nephropathy in Chronic Kidney Disease patients stages 2-4 |
Additional relevant MeSH terms:
Kidney Diseases Renal Insufficiency, Chronic Diabetic Nephropathies Proteinuria Urologic Diseases Renal Insufficiency Diabetes Complications Diabetes Mellitus Endocrine System Diseases Urination Disorders Urological Manifestations Signs and Symptoms |
Mycophenolic Acid Phosphodiesterase 5 Inhibitors Antibiotics, Antineoplastic Antineoplastic Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Phosphodiesterase Inhibitors |