Important clinical trials in the field of nephrology 

1-  DCOR Trial

Dialysis Clinical Outcome  Revisited 

2-  BEACON 

Bardoxolone Methylate in Type 2 DM stage 4 CKD

The most important lesson of the BEAM and BEACON trials is that eGFR is NOT measured GFR and that serum creatinine can go down for many non-GFR reasons; thus relying on eGFR was badly misleading. This a very important lessons for clinical trials on progression. In BEAM and BEACON RCTs weight loss and anorexia may have explained the wasting and decreased serum creatinine level; nothing to do with renal function!

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3- ONTARGET

Telmisartan + ramipril 

4-  ALTITUDE 

Aliskiren in type 2 DM

Not surprising as ras blockade is usually beneficial in dn, but dual and excessive ras blockade increasingly seems harmful and fraught with side effects; this also happened here. Also dont forget that bp control and outcomes in older patients, including diabetics, seem to follow some form of u shape with increased morbidity/mortality at low and high systolic bp levels.Also another example where reduction of proteinuria is not linked to good outcome! as with ONTARGET.

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5-  ACCOMPLISH

After a mean follow-up of 2.9 years, 113 patients in the benazepril/amlodipine arm progressed to CKD compared with 215 patients treated with the benazepril/hydrochlorothiazide combination. This translated into an absolute risk reduction of 1.7%, or a 48% relative reduction in risk. Similarly, there were significant reductions in the combined renal and cardiovascular death end point, as well as reductions in renal and all-cause mortality events. Among the 1093 patients with CKD, the progression of disease did not alter between the two treatment arms.

In ACCOMPLISH, the number of patients with proteinuria was small, an important caveat, he said, given new data suggesting that the level of proteinuria is an even better predictor of renal outcomes than the baseline level of GFR.

6-  EVOLVE

Cinacalcet

The advance trial showed benefit on vascular calcifications.The EVOLVE trial showed benefit on biochemical parameters.

However, different story when it comes to hard end points; neither morbidity (CVD and MACE) nor mortality have benefited.

Cinacalcet remains a useful drug to control severe hyperparathyroidism.

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7- ADVANCE

Cincalcet and calcification

8-  ESHOL 

ESHOL STUDY Showed Improved Overall Survivsl With Ol Hdf Than Standered Hd 30% Lower Risk In Death From Any Cause .....35% Lower Risk In Death From Cv Events .....50% Lower Risk In Death From Infection ......That Results Of The Study Suggested That After Conversion Of 8 Patients To This Modality , The Annual Death Decrease By One.....Also The Hospital Admission And Hypotension Complicated Hd Session Is Reduced With This Modality.

Are you convinced with ESHOL or is it all down to better selection of patients who confounded by indication means that thoise with better access, therefore better survival, are selected to go on hdf whilst the others stay on HD? of note the turkishHDF study and the contrast study failed to show benefit and the latest meta-analysis including Eshol Also implies no difference in outcomes between hd and HDF

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Review on Convection vs Diffusion Dialysis 

9- SIMPILICTY

Renal Denervation

Ultima Ratio or Standard in Treatment-Resistant Hypertension

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10-  CORAL 

Renal Artery stinosis intrvention management  .

Stenting atherosclerotic renal arteries 

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11-  VA NEPHRON DUAL BLOCKADE

Combined Angiotensin Inhibition for the Treatment of Diabetic Nephropathy . Combination therapy with an ACE inhibitor and an ARB was associated with an increased risk of adverse events among patients with diabetic nephropathy. 

12-  Sirolimus Vs Cyscosporine in de novo transplant  

Sirolimus did not prove to have superior eGFR compared to CSA and biopsy proven rejecions were higher in Sirolimus group and more side effects were observed in the same group.

13-  Five-Year Outcomes in Living Donor Kidney Transplants With a Positive Crossmatch

Still despite all advances in transplantation and medications related to it the HLA antibodies are headache that is difficult to manage. survival of graft and patieants are worse in positive cross match than negative ones. The  cost of transplantation itself is much higher than for negative cross match.

14-  Renal Transplantation After Ex Vivo Normothermic Perfusion: The First Clinical Study

Ex vivo normothermic perfusion (EVNP) is a novel method of preservation that restores circulation and allows an organ to regain function prior to transplantation. It helped reducing the DGF, patients and graft survival were the same at one year.

15-  BENEFIT  Trial randomized patients receiving a living or standard criterian deceased donor kidney transplanttoa more(MI) o rless intensive (LI) regimen of belatacept or cyclosporine A (CsA) Belatacept is a second-generation, higher avidity variant of abatacept. It differs from the parent molecule by two amino acids within the region that binds CD28-B7 (CD80, CD86), important co-stimulatory molecules required for full T cell activation. BENEFIT phase III  BENEFIT, one of the largest studies in kidney allograft recipients, belatacept was associated with similar patient and graft survival, superior renal function, a trend toward less chronic allograft nephropathy and an improved cardiovascular and metabolic profile compared with cyclosporine 1 year posttransplant, despite an increase in acute rejection in the early posttransplant period. Belatacept was generally safe and well tolerated. There appeared to be no additional efficacy gained using the belatacept MI regimen compared with the LI regimen. Belatacept is a new immunosuppressive therapy that avoids the renal and nonrenal toxicities associated with calcineurin inhibitors. 16-   Alemtuzumab Induction in Renal Transplantation  Permits Safe Steroid Avoidance with Tacrolimus Monotherapy. a single-center, prospective, open-label, randomized controlled trial comparing two steroid avoidance regimens between December 2006 and November 2010. One hundred and sixteen adult patients were randomized to either basiliximab induction followed by tacrolimus and MMF maintenance or to alemtuzumab induction followed by tacrolimus monotherapy. The primary endpoint was noninferiority of isotopic glomerular filtration rate at 1 year; secondary endpoints included patient and graft survival, incidence of delayed graft function, and incidence and severity of biopsy-proven acute rejection. The study concluded that : Renal transplantation with alemtuzumab induction followed by tacrolimus monotherapy leads to good graft and patient outcomes, with no major differences detected compared with basiliximab induction and tacrolimus/ MMF maintenance at 1 year. 17-  Sirolimus for Squamous Cell Carcinoma a 2 years randamized trial Conclusion: Despite some gains during the first year conversion to sirolimus-based immunosuppression failed to show a benefit in terms of SCC-free survival at 2 years.

18-  Efficacy of Transversus Abdominis Plane Block for Acute Postoperative Pain Relief in Kidney Recipients

A Double-Blinded Clinical Trial concluded that, the US-TAP block can reduce post-renal transplantation pain and the amount of opiate consumption intraoperatively and during the first 24 hours after surgery in patients with the same ASA classification

19-  Antibody-mediated vascular rejection of kidney allografts: a population-based study In conclusion, advances in HLA testing techniques, together with the ability to better characterise kidney allograft rejection histologically, have allowed different profiles of allograft rejection to be elucidated. Our study hasidentified a clinically relevant profile of rejection linking vascular rejection lesions in the allograft with circulatingdonor-specific anti-HLA antibodies (panel). The prognosisand course of this type of rejection is substantially differentfrom other types of rejection, with antibody-mediated vascular rejection having the poorest outcome. Because rejection is still the leading cause of kidney allograft loss, we hope that the recognition of this distinct type of rejection will lead to development of new treatment strategies that could salvage many kidney allograft
   
 

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