Department of Medicine
Dr. Parag Khatavkar
Study Title: Pulmonary rehabilitation delivered in low resource settings for people with chronic respiratory disease: a 3-arm assessor-blind randomised implementation trial
Status: Ongoing
Dr. Pradeep D'Costa
Study Title: A prospective, multicentre, randomised, active-controlled, observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the safety, tolerability and immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects
Status: Closed
Study Title: A randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among COVID-19 patients in India
Status: Closed
Cardiovascular Department
Dr. Milind Gadkari
Study Title: A Phase 3, randomised, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of Milvexian, an Oral Factor XIa Inhibitor, after a recent acute coronary syndrome. (LIBREXIA-ACS)
Duration: 3 Years 6 Months
Status: Ongoing
Study Title: “A Phase 3, randomised, double-blind, double-dummy, parallel group, active controlled study to evaluate the efficacy and safety of Milvexian, an Oral Factor Xla Inhibitor, versus Apixaban in participants with Atrial Fibrillation (LIBREXIA-AF)”
Duration: 3 Years
Status: Ongoing
Study Title: “HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation (EX6018-4915)”
Duration: 4 Years
Status: Ongoing
Study Title: A multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction ≥ 40% (LVEF ≥ 40%)
Duration: 4 Years
Status: Closed
Study Title: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)
Duration: 4 Years
Status: Closed
Study Title: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)
Duration: 4 Years
Status: Completed
Medicine Department: Nephrology – Renal Unit
Dr. Vipul Chakurkar
Study Title: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune-complex-mediated membranoproliferative glomerulonephritis (IC-MPGN)
Duration: 2 Years
Status: Ongoing
Study Title: A multicentre, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy
Duration: 2 Years
Status: Ongoing
Study Title: A multicentric, randomised, prospective, double blind, parallel group, comparative, active controlled, phase III clinical study to evaluate the efficacy, safety and tolerability of Fixed Dose Combination of Dapagliflozin 10 mg and Telmisartan 80 mg versus concurrent use Dapagliflozin 10mg tablets and Telmisartan 80mg tablets in patients with chronic kidney disease.
Duration: 6 Months
Status: Closed
Study Title: Catalytic iron and hepcidin in patients with COVID-19 and their association with adverse outcomes.
Duration: 1 Year
Status: Closed
Study Title: Catalytic iron and hepcidin in patients with COVID-19 and their association with adverse outcomes.
Duration: 1 Year
Status: Closed
Study Title: A multicentre, single-arm, open label trial to evaluate efficacy and safety of oral, twice daily LNP023 in adult aHUS patients who are naive to complement inhibitor therapy
Duration: 2 Years
Status: Ongoing
The Paediatric Nephrology Unit
Dr. Jyoti Singhal
Project Title: Clinical profile and short-term outcome of children with atypical haemolytic uremic syndrome
Duration: 3 Months
Status: Closed
Dr. Jyoti Sharma
Project Title: Genetics of Paediatric Kidney Diseases in Western in India: a Multicentre Registry
Duration: 6 Months
Status: Ongoing
Project Title: Optimal dosing regimen of cholecalciferol supplementation in children with chronic kidney disease-An open label multicentre randomised controlled trial Dr Jyoti Sharma Landmark trial completed in last 10 years Publications from this data: Iyengar A, Kamath N, Hamsa V, Uthup S, Sharma J, Singhal J, Sudha E, Rukshana S. Study Protocol: Determining the optimal dose of Cholecalciferol Supplementation in Children with Chronic kidney Disease (C3 trial): Design of an Open Label Multicentred Randomised Controlled Trial.”
Duration: 6 Months
Status: Closed
Diabetes Research Unit
Dr Yajnik
Study Title: Follow-up of children born in a B12-multi micronutrient supplementation primordial trial (PRIYA) to reduce diabesity risk and improve neurocognitive performance
Duration: 1 Year
Status: Ongoing
Study Title: Study of causal mechanisms of early life determinants of adiposity: Analysis in a longitudinal study
Duration: 3 Years
Status: Ongoing
Study Title: A type–II Hybrid effectiveness – Implementation trial of community health workers to improve screening for postpartum diabetes in urban slums of India
Duration: 5 Years
Status: Ongoing
Study Title: Maharashtra Anaemia Study Phase 3 (MAS3): Longitudinal study of nutritional, economic, and environmental impacts on anaemia, physical and cognitive development in Indian children from birth to age 18 years, nested within ‘The Pune Maternal Nutrition Study’ (PMNS)
Duration: 1 Year
Status: Closed
Study Title: Molecular basis of nutritional foetal programming of ‘diabesity’ - Pune Rural Intervention in Young Adolescents (PRIYA) trial
Duration: 5 Years
Status: Closed
Study Title: Molecular basis of nutritional foetal programming of ‘diabesity’ - Pune Rural Intervention in Young Adolescents (PRIYA) trial.
Duration: 5 Years
Status: Closed
Dr Rishikesh Behere
Study Title: Follow-up of children born in a B12-multi micronutrient supplementation primordial trial (PRIYA) to reduce diabesity risk and improve neurocognitive performance
Duration: 1 Year
Status: Ongoing
Dr Anand Ahankari
Study Title: Maharashtra Anaemia Study Phase 3 (MAS3): Longitudinal study of nutritional, economic, and environmental impacts on anaemia, physical and cognitive development in Indian children from birth to age 18 years, nested within ‘The Pune Maternal Nutrition Study’ (PMNS)
Duration: 1 Year
Status: Closed
Paediatric Research Unit
Dr. Sheila Bhave
Study Title: Persistence of immunogenicity of a single dose of Live Attenuated Hepatitis A Vaccine: A Follow-up Study 20 Years after vaccination
Duration: 6 Months
Status: Ongoing
Dr. Ashish Bavdekar
Study Title: A randomised, double-blind, placebo-controlled, phase 3 trial to investigate the safety and immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) administered subcutaneously to healthy subjects aged 4 to 60 years in India
Duration: 9 Months
Status: Ongoing
Study Title: Surveillance of viral pathogens causing respiratory infections
Duration: 4 Years
Status: Ongoing
Study Title: Enhancing capacity of KEM Hospital Research Centre, Pune for conduction of community-based human clinical trials on vaccines for COVID-19
Duration: 1 Year
Status: Closed
Study Title: Multicentric hospital-based surveillance of pertussis amongst infants admitted in tertiary care facilities in India
Duration: 2 Years
Status: Closed
Dr. Sandeep Kadam
Study Title: Risk factor, antibiotic sensitivity & outcome of culture – proven neonatal sepsis in intensive care unit: A 2 years retrospective study.
Duration: 2 Years
Status: Closed
Obstetrics and Gynaecology Department
Dr. Shubha Ambardekar
Study Title: Foetal Movement Awareness in Pregnancy – Utility, Compliance and Outcomes in Pregnancy - Pilot Study
Status: Completed
Dr. Suhas Otiv
Study Title: Respectful Maternity Care Initiative – ICMR Task Force Study in Collaboration with Centre for Catalyzing Change/White Ribbon Alliance India (WRAI)
Status: Completed
Study Title: Supplementation of Vitamin B12 to Improve B12-Folate ratio in Pregnancy and its Effect on Birth Outcome
Status: Completed
Study Title: National Registry on COVID-19 Infection Among Pregnant Women and Their Neonates
Status: Ongoing
Department of Medicine: Psychiatry Research Unit
Dr. Suchita Agarwal
Study Title: Exploring remote treatment strategy for persons with pedohebephilia in India
Duration: 10 Months
Status: Ongoing
Study Title: PATH India: Exploring Paedophilia - Access/Attitudes, Treatment, and Help-seeking in India.
Duration: 2 Years
Status: 2 Years
Dr. Rishikesh Behere
Study Title: Explaining resilience and vulnerability to the impact on mental health of the Covid – 19 pandemics in the Pune maternal nutrition study birth cohort.
Duration: 6 Months
Status: Ongoing
Dr. Vasudeo Paralikar
Study Title: The impact of the COVID-19 Pandemic on Well-Being, Stress, and Resilience of Adolescents and Caregivers in South Asia
Duration: 6 Months
Status: Ongoing
Study Title: Feasibility of expansion of clinical services and public health action to prevent & respond to sexual violence against children (Project with Charite, Berlin)
Duration: 1 Year
Status: Closed
Study Title: Program for Primary Prevention of Sexual Violence with a focus on treatment for persons with paedophilia (Project with Charite, Berlin)
Duration: 6 Months
Status: Closed
Study Title: Multinational field trial of CFI
Duration: 6 Months
Status: completed
Dr. Manjiri Datar
Study Title: Sociocultural framework for comprehensive case formulation of sexually gender diverse (LGBTIQI) Individuals
Duration: 1 Year 1 Month
Status: Ongoing
Dr Paralikar VP (Co-guide)
Study Title: Sociocultural framework for comprehensive case formulation of sexually gender diverse (LGBTIQI) Individuals
Duration: 1 Year 1 Month
Status: Ongoing
Dr. Ujjwal Nene
Study Title: Feasibility of expansion of clinical services and public health action to prevent & respond to sexual violence against children (Project with Charite, Berlin)
Duration: 1 Year
Status: Closed
Study Title: Program for Primary Prevention of Sexual Violence with a focus on treatment for persons with paedophilia (Project with Charite, Berlin)
Duration: 6 Months
Status: Closed
Medicine Department: Oncology Research Unit
Dr. Minish Jain
Study Title: A prospective, randomised, double blind, multicentric, parallel group Phase-III clinical study to evaluate the efficacy, safety, and immunogenicity of BP01 (Bevacizumab) versus EU approved Avastin® along with chemotherapy XELOX in metastatic colorectal cancer patients.
Duration: 2 Years
Status: Ongoing
Study Title: A prospective, multicentric, single arm, Open label, Phase IV Clinical study to evaluate safety and efficacy of DenosuRelTM containing Denosumab manufactured by Reliance Life sciences Pvt. Ltd. India for prevention of skeletal related events in patients with bone metastases from solid tumours. (RLS/PMS/2021/01)
Duration: 2 Years
Status: Ongoing
Study Title: Prospective, multi-centre, randomized, open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-023/ AvastinTM intravenously in patients with Metastatic colorectal cancer”
Duration: 2 Years
Status: Closed
Study Title: A multicentre, open label, randomised, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2 mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fed condition.
Duration: 2 Years
Status: Closed
Study Title: A prospective, multicentre, randomised, double blind, Phase III study to compare the efficacy and safety of Biosimilar Bevacizumab of Enzene Biosciences Ltd. versus Innovator Bevacizumab both in Combination with CAPEOX in Patients with Metastatic Colorectal Cancer
Duration: 1 Year 4 Months
Status: Closed
Social Science and Service Project Unit
Dr. Laila Garda
Study Title: Infosys Foundation’s Community Engagement Model for Maternal & Child Health
Status: Ongoing
Study Title: Addressing Water Scarcity and Hunger in Tribal Population - Soygaon Taluka, Maharashtra
Status: Closed
Ms. Varsha Tol
Study Title: Upscaling: Don’t Offend India – Initiative under Program for Primary Prevention of Sexual Violence (PPPSV)
Status: Ongoing
Study Title: Creating Sustainable Livelihoods and Economic Opportunities for Community with a Focus on Women and Youth in Rural and Urban Areas of Pune
Status: Closed