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

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Nazareth Hospital, Israel
• Collaborator: Western Galilee Hospital-Nahariya
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Phosphodiesterase 5 Inhibitors

Criteria

Inclusion Criteria:

1. T2 DM at age ≥18 y with at least 10 years duration of diabetes.

2. Proteinuria due to diabetic nephropathy of ≥ 2 gram/d treated with ACEi or ARBs at maximal tolerated dose or both of them.

3. CKD grade 1-3

4. Diabetic retinopathy (discuss with Zaid)

Exclusion Criteria:

1. Proteinuria of non diabetic origin

2. Overlap Proteinuria with diabetic nephropathy

3. Other intercurrent illness (fever due to infection ….) that can interfere with the urine protein secretion.

4. Acute Kidney Injury.

5. CKD stage 4-5.

6. New renoprotective treatment in the last 6 months before enrollment.

7. Changes in dosage of one of the renoprotective drugs in the last 6 months before enrollment.