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Global pharma reinforces India’s clinical trial capability for CKD medicines

Nandita Vijay, Bengaluru
Thursday, March 10, 2022, 08:00 Hrs  [IST]

Global pharma reinforces India’s clinical trial capability in chronic kidney disease (CKD) going by patient pool access and expertise. The country was not only part of stand-alone human studies but multi-centric global trials that provided new molecules in nephro drug regime.
 
Being the diabetes capital of the world, India is an automatic choice for novel kidney drug studies which included monoclonal antibodies for renal transplantation, drugs retarding the progression of diabetic nephropathy and CKD besides perfusion procedures.
 
According to Dr Anil Kumar BT, senior consultant nephrologist and transplant physician, BGS Gleneagles Global Hospital, trials going on for diabetes specially focussing on reno-protection or slowing kidney disease and cardiac protection known as the ‘Flow trial’ is an international multi-centric study. Other trials are for improving anaemia: HIF PHI drugs which can be orally administered. Our hospital is fortunate to be involved in both the trials.
 
Type 2 diabetic cases with CKD are three times more likely to succumb to cardiovascular disease (CVD). Sodium-glucose cotransporter-2 (SGLT2) Inhibitors are a new class of drugs found effective to control sugar by increasing the glucose excretion in urine. It also reduces the glomerular filtration pressures, lowers proteinuria and slows the progression of diabetic kidney disease, besides being beneficial control CVD and mortality, noted Dr. Vidyashankar P, lead consultant– nephrology and transplant physician, Aster CMI Hospital.
 
Contending with the nephrology fraternity was Dr. Vishwanath S, HOD & consultant- nephrology, transplant physician, Manipal Hospital who said that the new molecule ‘SGLT2’ inhibitor for diabetes proved to prevent kidney disease progression especially proteinuria along with cardiac protection in diabetics.  It also gives the benefit of weight loss in obese patients. Now this is a major breakthrough after ACE inhibitors and ARB drugs for diabetic kidney disease. There is a complete treatment available for hepatitis C virus infection which was otherwise a major problem in long-term dialysis patients providing cure rates of almost 100% with a 3-6 months course of newer antiviral drugs. These are drugs are cheaper in India which is a base for these human studies.
 
Further the kidneys produce a hormone ‘Erythropoietin which plays a key role in the formation of red blood cells. CKD cases are anaemic with erythropoietin deficiency. A new drug Desidustat is an oral alternative to injectable erythropoiesis-stimulating agents that is prescribed to both dialysis and non-dialysis patients, added Dr Vishwanath.
 
On the occasion of the World Kidney Day observed annually on March 10, nephrologists shudder to recall the first and second wave of the ongoing pandemic which saw CKD patients with lack of treatment access succumb to the disease. Transplants came to a standstill as hospitals were dedicated for Covid care resulting in the stoppage of all elective surgeries. Moreover, transplant patients on immunosuppressive drugs have high risk of Covid infection. Even regular maintenance dialysis patients suffered as their centres were shut with transport restrictions during the lockdown.
 
Adding to the woes of nephrologists to treat patients are lack of awareness about kidney diseases which is a key hindrance as most present themselves in the late stages of disease. This along with high treatment cost, paucity of dialysis units and nephro-care centres in the rural areas, poor patient compliance and caretaker fatigue for long term follow-ups sees xenotransplantation or stem cell therapies as a ray of hope for future.

 

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